Autoinjector having a settable dose

ABSTRACT

An autoinjector comprises a housing, a product container, a displaceable needle protection sleeve, a plunger rod displaceable by a preloaded discharge spring, a dose setting element with at least two different rotational positions relative to the housing, and a dosing sleeve. The dosing sleeve or the plunger rod has a dose selection stop, and the other has at least one dosing stop. By rotating the dose setting element, the dosing sleeve or the plunger rod is rotated relative to the other. Upon displacement of the needle protection sleeve, the spring displaces the plunger rod, whereby, if the dose setting element is in the first rotational position, the dose selection stop and the first dosing stop strikes against each other, and, if the dose setting element is in the second rotational position, one of the dose selection stop and the first dosing stop is or can be moved past the other.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/417,764 filed Jan. 27, 2017 and U.S. Pat. No. 10,493,212 issued Dec.3, 2019, which is a continuation of International Patent Application No.PCT/CH2015/000104 filed Jul. 13, 2015, which claims priority to SwissPatent Application No. CH 01161/14 filed Jul. 29, 2014. The entirecontents of each are incorporated herein by reference for any and allpurposes.

BACKGROUND

The invention relates to an autoinjector for administering a settabledose of a fluid product, in particular medication. The autoinjector ispreferably designed so that using it, a dose setting and only a singleproduct discharge are possible, and, after the single product discharge,the autoinjector is in a state that prevents an additional productdischarge. A product quantity that has not been discharged remains inthe autoinjector. Such autoinjectors can be referred to as a single-shotor single-use autoinjector device.

The term “medication” here comprises any free-flowing medicinalformulation that is suitable for controlled administration through ameans such as, for example, a cannula or hollow needle, comprising, forexample, a liquid, a solution, a gel or a fine suspension, whichcontains one or more medicinal active substances. A medication can be acomposition with a single active ingredient or a premixed orco-formulated composition with several active ingredients from a singlecontainer. Medications include drugs such as peptides (for example,insulins, insulin-containing medications, GLP-1-containing as well asderived or analogous preparations), proteins and hormones, biologicallyobtained or biologically active ingredients, active ingredients based onhormones or genes, nutrient formulations, enzymes, and other substanceseither in solid (suspended) or fluid form, but also polysaccharides,vaccines, DNA or RNA or oligonucleotides, antibodies or parts ofantibodies as well as suitable base, auxiliary and carrier substances.

Autoinjectors are known from the prior art. From EP 2 742 962A2, anautoinjector according is designed so that it can only completelydischarge the product quantity contained in its product container with asingle injection.

For certain therapies, it can be necessary to discharge only a certainquantity of the product contained in the product container. One approachwould be to fill the product container only with a desired product dose,so that the complete discharge of the product corresponds to thedischarge of the desired product dose. However, in that case, forexample, in a pharmacy, different autoinjectors with the same drug butdifferent filling quantities of the product container thereof would haveto be stored. It is simpler to provide an autoinjector that is filledwith a larger product quantity as desired and that is suitable fordischarging only some of this product quantity, wherein the autoinjectorincluding the residual quantity of the product remaining in theautoinjector is disposed of.

SUMMARY

One problem of the invention is to provide an autoinjector that enablesthe setting of a product dose to be discharged.

The problem is solved with an autoinjector having the features andadvantageous improvements from the claims, the description and thefigures.

The invention provides an autoinjector for administering a fluidproduct, in particular medication, wherein the autoinjector comprises:

-   -   a. a housing, which is preferably sleeve-shaped and elongate        with a longitudinal axis,    -   b. a product container, in particular a syringe, at a distal end        of which a needle is arranged, in particular detachably or        non-detachably, in which a piston is displaceably arranged,        which preferably forms a seal in contact with the wall of the        product container surrounding it, and which is retained in a        product container holder, which can also be referred to as        syringe holder, wherein the product container holder is        connected to the housing in an axially-fixed manner, preferably        permanently, in particular by a snap connection or by a        positive-lock connection, wherein the needle protrudes or        projects from the housing beyond the distal end of the housing,    -   c. a needle protection device, which, in particular, has the        function of a needle protection sleeve and of a triggering        device for the product discharge, wherein the needle protection        sleeve can be displaced from an initial position, in which the        distal end of the needle protection sleeve is distally beyond        the needle tip of the needle, in such a manner that, in        particular, access to the needle is prevented, into the housing,        in particular in the proximal direction, so that the needle        protrudes from the distal end of the needle protection sleeve,        in particular over a length that corresponds approximately to        the insertion depth of the needle, preferably for subcutaneous        injection, and    -   d. a plunger rod (e.g., tappet or transmission element) and a        discharge spring, wherein it is preferable that the discharge        spring is a coil spring acting as a compression spring, wherein        the plunger rod is arranged in the housing and can be displaced        by the preloaded discharge spring—in particular in the delivery        state of the autoinjector—which is preferably arranged at least        partially within the preferably sleeve-shaped plunger rod, along        a longitudinal axis of the autoinjector or of the housing in the        distal direction, wherein, as a result of the displacement of        the plunger rod in the distal direction, the piston, against        which the plunger rod strikes at least during the displacement,        is entrained or slaved by the plunger rod and displaces the        product from the product container, in particular via the        needle.

The autoinjector moreover comprises a dose setting element, whichpreferably forms an outer surface of the autoinjector and which can begripped by the user of the injector, wherein, in order to set a dose ofthe product to be discharged from the product container, the dosesetting element can be turned in relation to the housing, in particularby the muscle force of the user, and assume at least two differentrotational positions in relation to the housing, which preferablyquasi-stable rotational positions are in particular specified by meansof lock-in positions. A quasi-stable rotational position is understoodto mean that the dose setting element can be turned relative to thehousing only with increased torque from the respective quasi-stablerotational position, wherein the increased torque for loosening thequasi-stable rotational position is clearly higher than the slidingand/or adhesive friction for turning the dose setting element betweenthe at least two specified rotational positions.

The autoinjector moreover comprises a dosing sleeve, wherein one of thedosing sleeve and the plunger rod has a dose selection abutment and theother of the dosing sleeve and the plunger rod has at least one dosingabutment, wherein, as a result of the turning of the dose settingelement, one of the dosing sleeve and the plunger rod is turned inrelation to the other of the dosing sleeve and the plunger rod. The partthat is turned is connected or coupled, in particular directly orindirectly, i.e., via other parts of the autoinjector, to the dosesetting element. For example, as a result of the turning of the dosesetting element, a turning of the dosing sleeve relative to the plungerrod can occur. Alternatively, the turning of the dose setting elementcan cause a turning of the plunger rod relative to the dosing sleeve.The part that is not turned during the turning of the dose settingelement can be connected in a rotationally fixed manner, directly orindirectly, i.e., via at least one other part, to the housing of theautoinjector.

In a first rotational position of the at least two rotational positions,the dose selection abutment and a first dosing abutment of the at leastone dosing abutment are arranged in alignment along the longitudinalaxis. In alignment is understood to mean, in particular, that the doseselection abutment and the corresponding dosing abutment face oneanother along the longitudinal axis and can strike one another with apurely translational movement along the longitudinal axis.

In a second rotational position of the at least two rotationalpositions, the dose selection abutment is angularly offset about thelongitudinal axis relative to the first dosing abutment. i.e., inparticular, for the angular offset, the longitudinal axis forms therotation axis for the rotation angle. In principle, at least three, fouror more rotational positions can be provided.

The displacement of the needle protection sleeve into the housing causesthe discharge spring to displace the plunger rod in the distaldirection, in particular it causes a release of an engagement blockingthe plunger rod, which prevents the movement of the plunger rod in thedistal direction, whereby, as a function of the rotational position ofthe dose setting element, product quantities of different sizes can beor are discharged. If the dose setting element is in the firstrotational position thereof, one of the dose selection abutment and thefirst dosing abutment is moved toward the other—resting relative to thehousing, for example—of the dose selection abutment and of the firstdosing abutment. One of the dose selection abutment and the first dosingabutment thus strikes the other of the dose selection abutment and thefirst dosing abutment, in particular the one that is moving toward theother one.

When the dose setting element is in its second rotational position, oneof the dose selection abutment and the first dosing abutment is or canbe moved past the other of the dose selection abutment and the firstdosing abutment along the longitudinal axis. As a result, the plungerrod can perform a larger stroke than when the dose setting element is inthe first rotational position thereof, so that a larger dose can bedischarged from the product container.

For example, the plunger rod can comprise the dose selection abutmentand the dosing sleeve can comprise the at least one or a number ofdosing abutments. Alternatively, the plunger rod can have the at leastone dosing abutment or the multiple dosing abutments, wherein the dosingsleeve can have the dose selection abutment.

In an embodiment, the dose setting element can be a rotary knob attachedon the proximal end of the housing, which can be gripped by the user ofthe autoinjector and turned by muscle force, wherein the dose settingelement axially fixed relative to the housing can be turned, inparticular connected by snap connection in an axially fixed manner androtatably to the housing.

In addition, a lock-in device can be provided, which provides, inparticular, the quasi-stable, lock-in positions for the dose settingelement. In particular, the lock-in device can have, for example, foreach lock-in position, a recess, a groove on the housing or on anelement firmly attached to the housing, and a lock-in element which,depending on the rotational position of the dose setting element,engages in one of the recesses. The lock-in element can be attached onthe dose setting element or a part connected in a rotationally fixedmanner to the dose setting element, so that the lock-in element alsoturns with the dose setting element. Alternatively, for example, thelock-in device can have, for each lock-in position, a recess, inparticular a groove on the dose setting element, and a lock-in elementwhich, depending on the rotational position of the dose setting element,engages in one of the recesses. The lock-in element can be fastened onthe housing or on an element firmly attached to the housing, so that thedose setting element turns relative to the lock-in element during thedose setting.

In addition, in the second rotational position of the at least tworotational positions, the dose selection abutment and a second dosingabutment of the at least one dosing abutment can be arranged inalignment along the longitudinal axis. One of the dose selectionabutment and the second dosing abutment can move toward the other of thedose selection abutment and the second dosing abutment, wherein theother one is immobile, wherein, in particular, one of the dose selectionabutment and the second dosing abutment strikes against the other of thedose selection abutment and the second dosing abutment, when the dosingsetting element is in the second rotational position thereof, and thedischarge spring displaces the plunger rod in the distal direction.

In addition, the first dosing abutment and the second dosing abutmentcan be at a distance from one another along the longitudinal axis andarranged with angular offset about the longitudinal axis. In particular,the angular offset between the first and second dosing abutments cancorrespond to the angular offset between the first and second rotationalpositions.

In addition, the product container can comprise an abutment which, inparticular, can be formed by a tapering section between the cylindricalportion of the product container and the needle, against which thepiston strikes, when the dose setting element is in the secondrotational position thereof or in a third rotational position of therotational positions thereof, and the discharge spring displaces theplunger rod in the distal direction. For example, when the dose settingelement is in the third rotational position thereof, one of the doseselection abutment and the second dosing abutment is able to be moved orhas been moved past the other of the dose selection abutment and thesecond dosing abutment along the longitudinal axis.

In general, the dosing sleeve or a part of the autoinjector that isdifferent from the dosing sleeve and the product container can comprisean abutment, against which the dose selecting abutment of the plungerrod or another dose selection abutment of the plunger rod strikes, or ismoved toward the dose selection abutment, when the dose setting elementis in a second or in a third rotational position of the rotationalpositions thereof, and the discharge spring displaces the plunger rod inthe distal direction. The part that is different from the dosing sleeveand from the product container can be connected or coupled, for example,in an axially-fixed manner to the housing, or it can be formed by thehousing.

First Embodiment

In a first embodiment, the dose selection abutment can be formed on theplunger rod, wherein the at least one dosing abutment comprises a firstdosing abutment and a second dosing abutment, which are formed on thedosing sleeve, wherein the dosing sleeve is rotationally fixed relativeto the housing, and the plunger rod is connected in a rotationally fixedmanner to the dose setting element and can be turned together with thedose setting element relative to the housing and/or the dosing sleeve.

In an addition to the first embodiment, the dosing sleeve can comprise astop abutment, wherein a mechanism holder that is axially arrangedrelative to the housing and that preferably can be turned, which, inparticular, can be snapped in an axially fixed manner and rotatably tothe housing, can comprise a stop counter-abutment. The dose selectionabutment, during the movement of the plunger rod in the distaldirection, strikes against the first or second dosing abutment,depending on the rotational position of the dose setting element, andentrains the dosing sleeve in the distal direction, whereby the stopabutment is moved towards the stop counter-abutment, wherein themovement of the plunger rod and, in particular, of the dosing sleeve, inthe distal direction is blocked, when the stop abutment strikes the stopcounter-abutment.

Further, a displacement unit that comprises a first engagement unit thatengages in a recess of the mechanism holder, so that the displacementunit is held in an axially fixed manner relative to the housing, whereinthe first engagement unit is prevented by the dosing sleeve from movingout of the recess, when the stop abutment is at a distance from the stopcounter-abutment, wherein, due to the entrainment of the dosing sleeveby the plunger rod, the dosing sleeve is or can be moved out of theposition, in which the dosing sleeve prevents the first engagement unitfrom moving out of the recess. Advantageously, due to the dischargestroke, the entrainment of the dosing sleeve is achieved, and as aresult the blocking of the first engagement unit is released.

An additional prestressed spring may additionally be provided, which canalso be referred to as needle protection spring, which acts, inparticular with the proximal end thereof, on the displacement unit and,for example, can act with a distal end thereof directly or preferablyindirectly, such as, for example, via a switching sleeve, on the needleprotection sleeve, whereby the displacement unit is moved or can bemoved relative to the housing in the proximal direction, wherein,advantageously:

-   -   a. the displacement unit, during the movement in the proximal        direction against an immobile part of the autoinjector, strikes        and thereby generates a tactile and/or acoustic signal that        signals the end of the discharge of the set dose, wherein the        displacement unit is thus used as a signal generator or as a        means for generating a signal, and/or    -   b. the displacement unit, which is connected in a rotationally        fixed manner to the mechanism holder and to the dose setting        element, is moved or coupled by the movement in the proximal        direction into a rotationally fixed and, in particular,        positive-locking engagement with the housing or with an element        that is firmly attached to the housing, so that the dose setting        member is rotationally fixed relative to the housing about the        longitudinal axis, wherein, for example, the displacement unit        here acts as a coupling member, which is coupled in a        rotationally fixed manner in the positive-locking engagement to        the housing or to the element that is firmly attached to the        housing. The displacement unit can move in the proximal        direction, i.e., generate the signal and/or produce the        relatively fixed coupling, only when the first engagement unit        is moved or can be moved from the recess, i.e., when the dosing        sleeve or the stop abutment thereof strikes the stop        counter-abutment.

In addition to the first embodiment, the autoinjector that has beendescribed in general, can also be provided with a second engagementunit, which is preferably formed by the displacement unit thatdetachably engages in a recess of the plunger rod, and as a resultblocks the plunger rod in a movement relative to the housing in thedistal direction, wherein, in an (initial) rotational position of thedose setting element, a retaining surface of the housing or of anelement firmly connected to the housing prevents the second engagementunit from moving out of the recess, and, in the first and/or secondrotational position or in a priming rotational position of the dosesetting element, the retaining surface and the second engagement unitare separated with a rotational angle about the longitudinal axis, sothat the second engagement element can be moved from the recess of theplunger rod, and the plunger rod can be moved for performing a primingstroke from the discharge spring in the distal direction. The primingstroke is used to displace any air contained in the product containerfrom the product container and fill the fluid-conducting system up tothe needle tip with the fluid product. As a result, it is prevented thatair is injected into the patient, which is to be avoided.

In addition, the plunger rod can strike at the end of the priming strokeagainst a first engagement element engaging in a recess of the plungerrod, wherein it is preferable that the first engagement element beformed by a retaining element, against which the proximal end of thedischarge spring is braced, wherein the first engagement element blocksa movement of the plunger rod in the distal direction in a detachablemanner, wherein the needle protection sleeve, when it is moved into thehousing, displaces a locking sleeve from a position, in which thelocking sleeve prevents the first engagement element from being able tomove from the recess of the plunger rod, in the proximal direction intoa release position, wherein the locking sleeve has a recess, which, inthe release position along the longitudinal axis, coincidesapproximately with the position of a second engagement element of theretaining element, wherein the second engagement element is preferablyformed on the first engagement element, so that the second engagementelement can be moved into the recess, and, at the same time, the firstengagement element can be moved out of the engagement with the plungerrod, whereby the movement of the plunger rod in the distal direction isreleased for the discharge of the set dose.

Second Embodiment

A second embodiment of the autoinjector is characterized in that thedose selection abutment is formed on the plunger rod, wherein the atleast one dosing abutment comprises a first dosing abutment and a seconddosing abutment, which are formed on the dosing sleeve, wherein thedosing sleeve engages in a rotationally fixed manner relative to thehousing, in particular in a rotationally fixed manner in the housing orin a part that is firmly connected to the housing, wherein the plungerrod is connected or coupled in a rotationally fixed manner to the dosesetting element and can be turned together with the dose setting elementrelative to the housing and/or the dosing sleeve. A turning of the dosesetting element produces a rotation of the dose setting abutmentrelative to the first and second dosing abutments. Naturally, more thantwo dosing abutments such as, for example, eight dosing abutments ormore can be provided on the dosing sleeve.

For example, the dosing sleeve can be connected in an axially fixedmanner to the housing, in particular by a snap connection.Alternatively, the dosing sleeve can be connected displaceably to thehousing, wherein the dosing sleeve can be braced, for the axialfixation, against the proximal end of the syringe body of the productcontainer.

In addition, the dosing sleeve can comprise, in particular, a flexibleengagement element and/or an engagement element that can be moved towardthe longitudinal axis, engagement element, which engages in a firstrecess of the plunger rod that, in particular, is formed in the shape ofa slide, wherein the recess comprises a first abutment surface, which isin contact with the engagement element, whereby a movement of theplunger rod in the distal direction relative to the housing and/or thedosing sleeve is blocked. The first abutment surface can have beenturned or be able to be turned by turning the dose setting element and,in particular, by the turning transferred thereby to the plunger rod,out of the contact with the engagement element, whereby the axialblocking of the plunger rod is released, and the plunger rod can bedisplaced by means of the drive spring by a priming stroke in the distaldirection. At the end of the priming stroke, the engagement element isin contact with a second abutment surface that is preferably peripheralaround the plunger rod in the form of a ring, and that is formed by therecess. The distance existing along the longitudinal axis between thefirst and second abutment surfaces corresponds substantially to thepriming stroke. When the engagement element is in contact with thesecond abutment surface, the movement of the plunger rod in the distaldirection is blocked.

In addition, the needle protection sleeve, when it is moved into thehousing, in particular by means of a movement in the proximal directionand/or by an actuation stroke, can move a locking sleeve from aposition, in which it prevents the engagement element from being able tomove from the recess of the plunger rod, in the proximal direction intoa release position, wherein the locking sleeve, in the release position,releases a movement of the engagement element out of the recess, inparticular a movement of the engagement element transversely to thelongitudinal axis, as a result of which the movement of the plunger rodin the distal direction is released for the discharge of the set dose,in particular the movement of the plunger rod for a discharge stroke.

In addition, the plunger rod can be coupled in a rotationally fixedmanner to the dose setting element, when the engagement element is incontact with the first abutment and/or with the second abutment of therecess, and

-   -   a. it is rotationally uncoupled from the dose setting element        during the discharge of the dose, or    -   b. rotationally uncoupled, when the dose selection abutment is        in contact with the selected dosing abutment, in particular with        a first or second dosing abutment. As a result, the dose setting        element is rotationally uncoupled from the plunger rod, so that        torque can no longer be transferred from the dose setting        element to the plunger rod.

In addition, the autoinjector is characterized by a displacement unit,which is rotationally fixed and axially displaceable relative to thedosing sleeve, and which in particular surrounds the dosing sleeveand/or engages in a rotationally fixed manner or in an axially fixeddisplaceable manner in the dosing sleeve, and by a ring, which isrotatable about the longitudinal axis and which preferably surrounds thedosing sleeve and is mounted in particular on the dosing sleeve. Theturnable ring is in an axially fixed engagement—which can be released byturning—with the dosing sleeve, at least in a direction along thelongitudinal axis preferably in the proximal direction. The plunger rod,in particular the dose selecting abutment thereof, is designed so as toentrain the displacement unit toward the end of the discharge stroke,i.e., shortly before one of the dosing abutments or the selected dosingabutment is reached. In particular, during the discharge stroke, thedose selection abutment can strike against the displacement unit andentrain it, until the dose selection abutment strikes against one of thedosing abutments or the selected dosing abutment. The displacement unitcomprises, for example, a beveled transmission surface which, forexample, slides on a beveled gear counter-surface of the ring or ingeneral on the ring, whereby the ring is turned about the longitudinalaxis and out of the axially fixed engagement in which the ring standswith the dosing sleeve, so that a prestressed spring, in particular acoupling spring or snap spring, displaces or can displace the ring inthe proximal direction.

In particular, the spring can accelerate the ring against an axiallyfixed part of the autoinjector, in particular a coupling sleeve,whereby, at the time of the striking against the axially fixed part, anacoustic and/or tactile signal is generated, which signals the end ofthe discharge of the selected dose. Alternatively or additionally, thespring can displace the ring in a rotationally fixed engagement, inparticular in a groove of the dosing sleeve extending along thelongitudinal axis, whereby the ring is coupled in a rotationally fixedmanner to the dosing sleeve and/or the housing. Furthermore, thedisplacement of the ring by the spring has the effect that the ringassumes a position, in which the ring engages in a rotationally fixedmanner in the coupling sleeve, which in turn is coupled in arotationally fixed manner to the dose setting element, so that, inparticular, the turning of the dose setting element relative to thehousing is blocked. For example, the ring, together with the couplingsleeve, can form a claw coupling, which can be coupled with the movementof the ring in the proximal direction into the rotationally fixedcoupling engagement.

The coupling sleeve is preferably in a coupling engagement—which is, inparticular, detachable—with a plunger rod, when the engagement elementof the dosing sleeve is in contact with the first abutment and/or secondabutment of the recess of the plunger rod, wherein the couplingengagement is being detached or is detached during the discharge of thedose, when the dose selection abutment is in contact with the selecteddosing abutment.

Third Embodiment

A third embodiment of the autoinjector is characterized in that the doseselection abutment is formed on the dosing sleeve, wherein the at leastone dosing abutment comprises, for example, a first dosing abutment and,optionally, a second dosing abutment, wherein the dosing abutment or thedosing abutments are formed on a plunger rod, wherein the plunger rod isrotationally fixed relative to the housing, wherein the dosing sleeve isconnected or coupled in a rotationally fixed manner to the dose settingelement and can be turned together with the dose setting elementrelative to the housing and/or the plunger rod, wherein the dosingsleeve is connected, for example, in an axially fixed manner to thehousing.

The dosing sleeve can comprise a main section, a spring section and asection resiliently arranged distally from the main section along thelongitudinal axis by means of the spring section. The main section orthe resiliently arranged section can form the dose selection abutment.

In addition, a rotation prevention sleeve, which connects the plungerrod and the housing in a manner that prevents rotation can be provided,wherein the rotation prevention sleeve is arranged between theresiliently arranged section of the dosing sleeve and a proximal end ofthe product container, in particular, a finger flange, so that thespring section of the dosing sleeve presses the product container viathe rotation prevention section, which is preferably axiallydisplaceable relative to the housing, into a firm seating with theproduct container holder.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exploded view of an autoinjector according to a firstembodiment.

FIGS. 2a-2c show the first embodiment in a delivery state, wherein FIGS.2a to 2c are cross-sectional views extending through the longitudinalaxis of the device, wherein the longitudinal sections are angularlyoffset about the longitudinal axis.

FIG. 3 shows the first embodiment with a removed pull-off cap.

FIGS. 4a-4b show the first embodiment, wherein a priming is released.

FIGS. 5a-5b show the first embodiment after the priming.

FIGS. 6a-6b show the first embodiment during a dose setting.

FIGS. 7a-7b show the first embodiment in a state in which the needleprotrudes over the distal end of the autoinjector and the autoinjectoris released.

FIGS. 8a-8b show the first embodiment during the generation of aclicking sound, which signals the beginning of the injection.

FIGS. 9a-9b show the first embodiment in a state in which the product isdischarged,

FIGS. 10a-10b show the first embodiment during the generation of aclicking sound, which signals the end of the injection.

FIG. 11a-11c show the first embodiment in a state in which the needleprotection sleeve covers the needle and is blocked from being pushedback.

FIG. 12 shows an exploded view of an autoinjector according to a secondembodiment.

FIG. 13a-13b show the second embodiment in a delivery state, whereinFIGS. 13a and 13b are cross-sectional views extending through thelongitudinal axis of the device, wherein the cross-sectional views areangularly offset about the longitudinal axis.

FIGS. 14a-14b show the second embodiment with a removed pull-off cap.

FIG. 15 shows the second embodiment in a state, in which a priming isreleased.

FIG. 16 shows the second embodiment, wherein an insertion of the needleis released.

FIG. 17 shows the second embodiment in a state, in which the priming iscarried out.

FIG. 18 shows the second embodiment in a state in which a dose selectionhas been carried out.

FIGS. 19a-19b show the second embodiment in a state in which a needleprotrudes beyond the distal end of the autoinjector and releases aninjection.

FIG. 20 shows the second embodiment, in which a clicking sound isissued, which signals the end of the injection.

FIG. 21 shows the second embodiment in a state in which the clickingsound, signaling the end of the injection, has been generated.

FIG. 22 shows the second embodiment with a needle protection sleevelocked against being pushed back, in a needle protection position.

FIG. 23 shows an exploded view of an autoinjector according to a thirdembodiment.

FIGS. 24a-24c show the third embodiment in a delivery state, whereinFIGS. 24a to 24c are cross-sectional views extending through thelongitudinal axis of the device, wherein the cross-sectional views areangularly offset about the longitudinal axis.

FIG. 25 shows the third embodiment with a removed pull-off cap.

FIGS. 26a-26b show the third embodiment during a dose setting.

FIGS. 27a-27b show the third embodiment in a released state.

FIG. 28 shows the third embodiment, wherein a signal signaling the startof the product discharge is generated.

FIG. 29 shows the third embodiment, wherein the generation of a signalsignaling the end of the product discharge is prepared.

FIGS. 30a-30b show the third embodiment after the discharge of theproduct dose has occurred.

FIGS. 31a-31b show the third embodiment, wherein the signal signalingthe end of the product discharged is generated.

FIGS. 32a-32b show the third embodiment with a needle protection sleeveblocked against being pushed back, in a needle protection position.

DETAILED DESCRIPTION First Embodiment

In reference to FIGS. 1 to 11 b, the structural features and thefunction of the autoinjector according to the first embodiment are nowdescribed.

The autoinjector comprises a sleeve-shaped, elongate housing 2 with alongitudinal axis L, which, at its proximal end, comprises asleeve-shaped housing insert 12 that is connected with positiveconnection to the housing 2 in a rotationally and axially fixed manner,and that is arranged at the proximal end of the housing 2. Thesleeve-shaped housing insert 12 comprises a lock-in catch 12 c. A dosesetting element 16 comprises several, in particular at least two, or inaccordance with the number of settable doses, lock-in grooves 2 fdistributed over the periphery, wherein the lock-in catch 12 c engagesin the lock-in grooves 2 f, and, when the dose setting element 16 isturned, for example, for a dose setting, the lock-in catch 12 c is movedfrom the lock-in groove 2 f and into another of the lock-in grooves 2 fAs a result, quasi-stable lock-in positions for the dose setting element16 are specified.

The sleeve-shaped dose setting element 16 is connected on the proximalend of the housing 2 rotatably and in an axially fixed manner to thehousing 2, in particular by snap connection, and, in particular, itforms the proximal end of the autoinjector. The dose setting element 16can be gripped by the user of the device and turned relative to thehousing 2 by the muscle force of the user for the setting of a productdose to be discharged. For example, by means of the device, severalvariable doses can be set in different small increments. For example,the dose setting element 16 can assume, relative to the housing, atleast two different quasi-stable rotational positions, or in accordancewith the number of settable doses, for example eight differentquasi-stable rotational positions, distributed over the periphery,wherein, in a first rotational position, a first dose is set, and, in asecond rotational position, a second dose is set, etc.

On the distal end of the autoinjector, in its delivery state (FIGS. 2ato 2c ), a pull-off cap 4 is arranged, which is pulled or twisted off,before the use of the autoinjector, and removed.

In the housing 2, a product container 13, in the form of a syringe, isaccommodated in a manner so it cannot be displaced relative to thehousing 2—except for the installation of the autoinjector—along thelongitudinal axis L. The product container 13 comprises a sleeve-shapedsyringe body, which surrounds a piston 13 b and which is in sealingcontact with the inner periphery of the syringe body. On its distal end,the syringe body comprises, in particular, an injection needle 13 a,which is connected detachably to the syringe body and whose distal endis formed by the needle tip. Between the injection needle 13 a and thepiston 13 b, a fluid product, in particular medication, is arrangedwithin the syringe body, wherein the displacement of the piston 13 b ina discharge direction, i.e., in the distal direction or toward theinjection needle 13 a, discharges the product through the hollowinjection needle 13 a from the product container 13. On its proximalend, the syringe body has a so-called finger flange, which protrudesradially outward over the periphery of the cylindrical syringe body.

The product container 13 is accommodated in a product container holder1, referred to below as syringe holder 1, in such a manner that it isprotected against being moved along the longitudinal axis L in thedistal direction relative to the syringe holder 1. As can be seen in theexample of FIG. 2a , the syringe holder 1 is connected by positiveconnection to the housing 2. The housing 2, for this purpose, hasrecesses into which the lock-in elements, formed here on the proximalend of the syringe holder 1, engage. The syringe holder 1 has at leastone inward protruding shoulder 1 b, against which is braced a taperingsection of the product container 13, which is arranged distally withrespect to the cylindrical syringe body section which guides the piston13 b.

The autoinjector comprises a dosing sleeve 5 which is arranged in thehousing 2 and which is arranged, relative to the housing 2 and to aplunger rod 7, in a manner so it is rotationally fixed and axiallymovable. The dosing sleeve 5 is connected in a rotationally fixed andaxially displaceable manner to a retaining ring 19, which is connectedin a rotationally fixed and preferably axially fixed manner to thehousing 2, in particular by snap connection.

In order to prevent the product container 13 from being able to bedisplaced relative to the syringe holder 1 in the proximal direction,the product container 13 is pressed on its proximal end by a holderspring section 5 c formed by the retaining ring 19 into the engagementwith the shoulder 1 b. By means of the holder spring section 5 c,longitudinal differences of the product container 13, which can occurdue to manufacturing tolerances, can be compensated, wherein the firmseating of the product container 13 on the shoulder 1 b is ensured.

The product container 13 is arranged, relative to the housing 2, in sucha manner that the needle tip is distally beyond the distal end of thehousing 2. In the initial or delivery state of the autoinjector, i.e.,when the pull-off cap 4 is arranged on the autoinjector, the needle 13 ais formed by a needle protection cap 14 which, in the depicted example,is referred to as a so-called rigid needle shield known to the personskilled in the art, alternatively known as a soft needle shield, inorder to protect the needle 13 a against soiling or to keep the needle13 a and the medication sterile. The rigid needle shield 14 is arrangedon a needle holder section of the syringe body, wherein the taperingsection of the syringe body is located between the needle holder sectionand the cylindrical section of the syringe body. The shoulder 1 b isarranged between the syringe body and the proximal end of the rigidneedle shield 14, in particular so that, between the rigid shield 14 andthe shoulder 1 b, a gap—albeit a small gap—is produced in order toprevent the shoulder 1 b exerting a force on the rigid needle shield 14,whereby, for example, the sterility of the needle 13 a and of the fluidproduct could be impaired. The pull-off cap 4 is snapped detachably tothe housing 2 or a needle protection sleeve 3, wherein this snapconnection is loosened, when the pull-up cap 4 is removed from thehousing 2 or the needle protection sleeve 3. The pull-off cap 4 moreovercomprises, in particular on a flexible arm, at least one catch 4 b,which engages in a gap between the syringe body, in particular itstapering area, and the proximal end of the rigid needle shield 14. Whenthe pull-off cap 4 is removed from the autoinjector, the catch 4 b hooksinto the proximal end of the rigid needle shield 14, as a result ofwhich the rigid needle shield 14 is detached from the product container13 and removed together with the cover cap 4 from the autoinjector (FIG.3).

The autoinjector has a needle protection sleeve 3, which is displaceablerelative to the housing 2 and along the longitudinal axis L by anactuation stroke H_(B) in the proximal direction into an actuatedposition, in order to trigger a product discharge. In the initialposition of the needle protection sleeve 3, as shown in FIGS. 6a, 6b ,wherein the pull-off cap 4 is removed, the distal end of the needleprotection sleeve 3 is distally beyond the needle tip of the needle 13a, so that access to the needle tip is at first prevented. By shiftingthe needle protection sleeve 3 by the actuation stroke H_(B), the needleprotection sleeve 3 is displaced in the proximal direction until theneedle 13 a protrudes from the distal end of the needle protectionsleeve 3, in particular over a length that corresponds to the injectiondepth of the needle in the injection site. Preferably, the needle 13 ashould protrude beyond the distal end of the needle protection sleeve 3by a distance such that a subcutaneous injection can occur. Inparticular, the housing 2 can form an abutment, with which the needleprotection sleeve 3 is in contact in the actuated position.

After the injection has taken place, the needle protection sleeve 3 canbe displaced, relative to the housing 2, from the actuated positionalong the longitudinal axis L by a needle protection stroke H_(N) in thedistal direction into a needle protection position (FIGS. 11a, 11b ). Inthe needle protection position, the distal end of the needle protectionsleeve 3 extends distally beyond the needle tip, so that access to theneedle tip is prevented and the risk of injury is reduced. As describedfurther below, the needle protection sleeve 3 can be blocked againstbeing again pushed back out of the needle protection position.

The syringe holder 1 has a bevel 1 a facing radially outward, whereinthe beveling 1 a engages in in a slit-shaped recess of the needleprotection sleeve 3, which is arranged between the housing 2 and thesyringe holder 1. In the initial position of the needle protectionsleeve 3 (FIGS. 6a, 6b ) and/or in the needle protection position of theneedle protection sleeve 3 (FIGS. 11a, 11b ), the needle protectionsleeve 3, in particular the proximal end of the slit-shaped recess, isin contact with the bevel 1 a, whereby a movement of the needleprotection sleeve 3 in the distal direction is prevented. Into thisslit-shaped recess, alternatively in another recess of the needleprotection sleeve 3, a cam 1 c, arranged resiliently on the syringeholder 1 and formed by the syringe holder 1, can engage. The cam 1 c isdesigned so that, when an attempt is made to displace the needleprotection sleeve 3 from the initial position into the actuatedposition, the cam 1 c at first prevents the displacement of the needleprotection sleeve 3, wherein the cam 1 c is pressed out, when the forceexerted on the needle protection sleeve 3 for pushing back exceeds acertain threshold value, whereby the needle protection sleeve 3 isabruptly pushed back into the actuated position. As a result, the needle13 a can be inserted abruptly into the insertion site. In order toinsert the needle 13 a or in order to displace the needle protectionsleeve 3 into the actuated position, the distal end of the needleprotection sleeve 3 is placed on the insertion site, wherein the housing2 is then pressed in the direction of the insertion site, wherein, whenthe compressive force exceeds the above-mentioned threshold value, thehousing 2 is displaced abruptly toward the insertion site, and theneedle protection sleeve 3 is displaced relative to the housing 2 by theactuation stroke H_(B) into the actuated position.

The autoinjector comprises a sleeve-shaped plunger rod 7 which forms, atits distal end, an inward protruding shoulder, against which a firstspring 9 is braced, which can also be referred to as a discharge spring.The first spring 9 is arranged within the sleeve-shaped plunger rod 7.The first spring 9 is a compression spring acting as a coil spring thatis sufficiently prestressed with energy in the initial or delivery stateof the autoinjector, so that the product contained in the productcontainer 13 can be discharged, in particular completely, by thedisplacement of the plunger rod 7 by a discharge stroke H_(A), from theproduct container 13. In the delivery state of the device, there is adistance between the piston 13 b and the distal end of the plunger rod7, so that the plunger rod 7 strikes the piston 13 b only during theperformance of the priming stroke H_(P), entraining said piston in thedischarge direction. The first spring 9 is braced with its proximal endagainst a retaining element 6, which, in this example, has two arms 6 c,wherein, on each arm 6 c, a first engagement element 6 a and a secondengagement element 6 b are arranged. The first engagement element 6 afaces the longitudinal axis L radially, wherein the second engagementelement 6 b faces radially away from the longitudinal axis L. The firstengagement element 6 a engages in a first recess 7 a formed by theplunger rod 7. In the delivery state of the autoinjector or before theperformance of a priming, the proximal end of the first recess 7 a is ata distance from the first engagement element 6 a of the retainingelement 6, which corresponds to the priming stroke H_(P) (FIG. 2b ). Alocking sleeve 8, which can be shifted along the longitudinal axis L,holds the first engagement element 6 a, in particular with its innerperipheral surface, in the engagement with the recess 7 a of the plungerrod 7.

A sleeve-shaped displacement unit 11 comprises a flexible firstengagement element 11 a, which engages in a recess 17 b of asleeve-shaped mechanism holder 17, whereby the displacement unit 11 isaxially fixed relative to the mechanism holder 17 as long as there isengagement. The mechanism holder 17 is snapped in an axially fixed androtatable manner relative to the housing 2, in particular in an axiallyfixed and rotatable manner to the sleeve-shaped housing insert 12. Thedisplacement unit 11 comprises a second engagement unit 11 b, whichengages in a second recess 7 b of the plunger rod 7, whereby the plungerrod 7 is blocked by the second engagement unit 17 b of the sleeve-shapedmechanism holder 17 from being moved in the distal direction. Thesleeve-shaped housing insert 12 has a retaining surface 12 d, with whichthe second engagement element 11 b of the displacement unit 11 is incontact and which is held in engagement with the second recess 7 b ofthe plunger rod 7.

On its outer periphery, the plunger rod 7 comprises a dose selectionabutment 100 in the form of a protrusion. The dosing sleeve 5 comprises,distributed over its periphery, several, namely at least a first dosingabutment 110 (FIG. 2b ) and a second dosing abutment 111 (FIG. 6b ),which are angularly offset relative to one another about thelongitudinal axis L and arranged along the longitudinal axis L indifferent axial positions. The dosing sleeve 5 comprises, in particularon its outer periphery, a stop abutment 5 e, which is located at adistance opposite a stop counter-abutment 17 a formed along thelongitudinal axis L by the mechanism holder 17 (FIG. 2a ).

For administering the medication, the pull-off cap 4 is removed togetherwith the rigid needle shield 14 from the autoinjector (FIG. 3).Subsequently, the autoinjector is primed (FIGS. 4a, 4b ). For thispurpose, the dose setting element 16 is turned relative to the housing2. The plunger rod 7 is connected, in particular via the retainingelement 6, in a rotationally fixed manner to the dose setting element16. The displacement unit 11 is connected in a rotationally fixed mannerto the plunger rod 7 and the mechanism holder 17. The mechanism holder17 in turn is connected in a rotationally fixed manner to the lockingsleeve 8, wherein the locking sleeve 8 is connected in a rotationallyfixed manner to a switching sleeve 15. When the dose setting element 16is turned, the displacement unit 11 in particular is also turned,wherein the second engagement element 11 b is turned from theoperational engagement with the retaining surface 12 d of the housinginsert 12 which is rotationally fixed relative to the housing 2,wherein, in a position in which the second engagement unit 11 b and theretaining surface 12 d are angularly offset relative to one anotherabout the longitudinal axis L, in particular in the first or secondrotational position, the engagement element 11 b of the displacementunit 11 is pushed out of the engagement with the second recess 7 b ofthe plunger rod 7 due to the action of the prestressed discharge spring9, in particular with a movement transverse to the longitudinal axis L(FIG. 4b ). The prestressed discharge spring 9 displaces the plunger rod7 by the priming stroke H_(P) in the distal direction, until theproximal end of the first recess 7 a of the plunger rod 7 strikesagainst the first engagement element 6 a, as a result of which themovement of the plunger rod 7 in the distal direction is blocked. Duringthe priming stroke H_(P), the plunger rod 7 entrains the piston 13 b,whereby the syringe 13 is primed (FIG. 5b ).

Now the dose setting can occur (FIGS. 6a, 6b ). For this purpose, thedose setting element 16 is turned into one of the several rotationalpositions such as, for example, the first or second rotational positionrelative to the housing 2. The plunger rod 7, the retaining element 6,the displacement unit 11, the mechanism holder 17, the locking sleeve 8,the switching sleeve 15, and a second spring 10 also turn with the dosesetting element 16. In particular, by means of the turning of the dosesetting element 16, the dose setting abutment 100 of the plunger rod 7is turned relative to the first and second dosing abutments 110, 111 ofthe dosing sleeve 5. In the first rotational position of the dosesetting element 16, the dose selection abutment 100 and the first dosingabutment 110 are arranged in alignment along the longitudinal axis L. Inthe second rotational position of the dose setting element 16, the doseselection abutment 100 is angularly offset about the longitudinal axis Ltoward the first dosing abutment 110 and in alignment with the seconddosing abutment 111 (FIG. 6b ).

In order to trigger the administration of the set product dose, i.e., inorder to release the engagement of the first engagement unit 6 a of theretaining element 6 from the recess 7 a of the plunger rod 7, the needleprotection sleeve 3 is displaced by the actuation stroke H_(B) in theproximal direction into the housing 2. As a result, the proximal end 3 aof the needle protection sleeve 3 entrains the switching sleeve 15,whereby the second spring 10, in particular the needle protection spring10, is stressed. The switching sleeve 15 abuts, during its movement inthe proximal direction, against the locking sleeve 8 and it alsoentrains the locking sleeve 8. Due to the movement of the locking sleeve8 in the proximal direction, a first recess 8 b of the locking sleeve 8is displaced along the longitudinal axis L approximately into theposition of the second engagement unit 6 b, whereby the prestresseddischarge spring 9 displaces the plunger rod 7 by a discharge strokeH_(A) in the distal direction, whereby the first engagement unit 6 a ofthe retaining element 6 is moved from the engagement with the recess 7 aof the plunger rod 7 and at the same time the second engagement element6 b of the retaining element 6 is moved into the recess 8 b of thelocking sleeve 8, in particular with a movement transversely to thelongitudinal axis L (FIG. 7a ). Due to the movement of the lockingsleeve 8 in the proximal direction, a second recess 8 c of the lockingsleeve 8 is displaced along the longitudinal axis L approximately intothe position of a locking member 17 c of the mechanism holder 17. Thedose selection abutment 100 is moved toward the second dosing abutment111 and past the first dosing abutment 110, until the dose selectionabutment 100 strikes against the second dosing abutment 111 of thedosing sleeve 5, and entrains the dosing sleeve 5 at least over adistance, namely by the distance between the stop abutment 5 e and thestop counter-abutment 17 a of the mechanism holder 17, until the stopabutment 5 e impacts against the stop counter-abutment 17 a, as a resultof which the movement of the dosing sleeve 5 in the distal direction andthus also the movement of the plunger rod 7 in the distal direction areblocked. Due to the movement of the dosing sleeve 5 in the distaldirection, said dosing sleeve 5 is moved from the position in which itprevents the first engagement element 11 a of the displacement unit 11from being able to be displaced from the recess 17 b of the mechanismholder 17 (FIG. 9b ). Due to the movement of the dosing sleeve 5 in thedistal direction, the dosing sleeve 5 presses the locking member 17 c ofthe mechanism holder 17 into the second recess 8 c of the locking sleeve8, in particular with a movement transverse to the longitudinal axis L(FIG. 7a ), whereby a movement of the locking sleeve 8 in the distaldirection is blocked.

When the second engagement element 6 b of the retaining element 6engages with the recess 8 b of the locking sleeve 8, the proximal end ofthe discharge spring 9 can accelerate the retaining element 6 in theproximal direction, wherein the engagement element 6 b also acceleratesthe locking sleeve 8 in the proximal direction, wherein the lockingsleeve 8, after the performance of a signal stroke H_(K), strikesagainst the mechanism holder 17, and, as a result, a tactile and/oracoustic signal is generated (FIGS. 7a to 8b ), signaling the start orbeginning of the product discharge. In addition, by means of the secondengagement element 6 b, which is in engagement with the recess 8 b ofthe locking sleeve 8, the movement of the locking sleeve 8 in the distaland proximal directions is blocked.

Since—as can be seen in FIGS. 9a, 9b —the blocking of the firstengagement unit 11 a of the displacement unit 11 by the dosing sleeve 5at the end of the discharge H_(A) is omitted, the stressed second spring10, which is braced with its proximal end against a protrusion 11 c ofthe displacement unit 11, can accelerate the displacement unit 11 in theproximal direction, wherein the first engagement unit 11 a is releasedfrom the engagement with the first recess 17 b. The displacement unit 11is accelerated by a signal stroke H_(S) in the proximal direction, untilit abuts against the sleeve-shaped housing insert 12 and generates anacoustic and/or tactile signal, indicating the end of the productdischarge. The movement of the displacement unit 11 in the proximaldirection moreover has the effect that the displacement unit 11, inparticular the protrusion 11 c, is moved in a positive-lockingrotation-preventing engagement with the housing 2 or the sleeve-shapedhousing insert 12, whereby a turning of the displacement unit 11relative to the housing 2 about the longitudinal axis L after theproduct discharge has occurred is prevented. Since the dose settingelement 16 is connected in a rotationally fixed manner to thedisplacement unit 11, a turning of the dose setting element 16 relativeto the housing 2 is blocked (FIG. 10a ).

When the autoinjector is removed from the insertion site, the secondspring 10 displaces the switching sleeve 15 relative to the housing 2and/or the locking sleeve 8 in the distal direction, wherein theswitching sleeve 15 displaces the needle protection sleeve 3 in thedistal direction by the needle protection stroke H_(N). Due to theengagement of the second engagement element 6 b of the retaining element6 with the recess 8 b of the locking sleeve 8, the movement of thelocking sleeve 8 in the distal and proximal directions is prevented, sothat the switching sleeve 15 moves relative to the locking bar 8 and, atthe end of the movement, is snapped in an axially fixed manner to thelocking sleeve 8, in particular by means of a locking member 8 a (FIG.11c ) of the locking sleeve 8 engaging in the switching sleeve 15, sothat, when an attempt is made to displace the needle protection sleeve 3in the proximal direction, this movement is blocked. In the process, thelocking sleeve 8 is pressed against the mechanism holder 17, which isconnected in an axially fixed manner to the housing 2 and which blocksthe movement of the locking sleeve 8 in the proximal direction.

Second Embodiment

In reference to FIGS. 12 to 22, the structural features and the functionof the autoinjector according to the second embodiment are nowdescribed.

The autoinjector has a sleeve-shaped, elongate housing 2 with alongitudinal axis L, which, on its proximal end, comprises asleeve-shaped housing insert 12, which is connected by positive lock tothe housing 2 in a rotationally and axially fixed manner and arranged onthe proximal end of the housing 2. The sleeve-shaped housing insert 12has a lock-in catch. A dose setting element 16 comprises several, inparticular at least two, or in accordance with the number of settabledoses, lock-in grooves distributed over the periphery, wherein thelock-in catch engages in one of the lock-in grooves, and, when the dosesetting element 16 is turned such as, for example, for a dose setting,it is moved from the lock-in groove and into another one of the lock-ingrooves. As a result, quasi-stable lock-in positions are specified forthe dose setting element 16.

The sleeve-shaped dose setting element 16 is connected, particularly bysnap connection, on the proximal end of the housing 2 rotatably and inan axially fixed manner to the housing 2, forming, in particular, theproximal end of the autoinjector. The dose setting element 16 can begripped by the user of the device and turned relative to the housing 2by the muscle force of the user for setting a product dose to bedischarged. For example, by means of the device, several doses can beset in different mL steps. For example, the dose setting element 16 canassume, relative to the housing, at least two quasi-stable rotationalpositions, or, in accordance with the number of settable doses, forexample, eight different quasi-stable rotational positions, wherein, ina first rotational position, a first dose is set, and in a secondrotational position, a second dose is set.

On the distal end of the autoinjector, in its delivery state (FIGS. 13a,13b ), a pull-off cap 4 is arranged, which is pulled or twisted offbefore the use of the autoinjector, and removed.

In the housing 2, a product container 13 in the form of a syringe isaccommodated in a nondisplaceable manner relative to the housing2—except for the installation of the autoinjector—along the longitudinalaxis L. The product container 13 has a sleeve-shaped syringe body, whichsurrounds a piston 13 b, which is in sealing contact on the innerperiphery of the syringe body. The syringe body, on its distal end,comprises an injection needle 13 a, which, in particular, is connectedin an undetachable manner to the syringe body and whose distal end isformed by the needle tip. Between the injection needle 13 a and thepiston 13 b, a liquid product, in particular medication, is arrangedwithin the syringe body, wherein the displacement of the piston 13 b ina discharge direction, i.e., in the distal direction or toward theinjection needle 13 a, discharges the product through the hollowinjection needle 13 a from the product container 13. The syringe body,on its proximal end, has a so-called finger flange, which protrudesradially outward over the periphery of the cylindrical syringe body.

The product container 13 is accommodated in a product container holder1, hereafter referred to as syringe holder 1, in such a manner that itis protected at least against a movement along the longitudinal axis Lin the distal direction relative to the syringe holder 1. The syringeholder 1, as can be seen in FIG. 13a , for example, is connected to thehousing with a positive-lock connection, in particular engaged. For thispurpose, the housing 2 has recesses, which engage in the lock-inelements formed here on the proximal end of the syringe holder 1. Thesyringe holder 1 has at least one inward protruding shoulder 1 b,against which is braced a tapering section of the product container 13,which is arranged distally with respect to the cylindrical syringe bodysection guiding the piston 13 b.

The autoinjector comprises a dosing sleeve 5, which is arranged in thehousing 2 and which is arranged in a rotationally fixed manner andaxially movable relative to the housing 2 and a plunger rod 7. Thedosing sleeve 5 engages in a rotationally fixed and axially movablemanner in the housing 2. The dosing sleeve 5 comprises an engagementelement 6 a, which is formed on an arm 6 c of the dosing sleeve 5, inparticular forming a single part, in such a manner that it can bedeflected flexibly transversely to the longitudinal axis L. Theengagement element 6 a of the dosing sleeve 5 engages in a plunger rod 7and blocks the plunger rod 7 against a movement in the distal direction.On the plunger rod 7, a prestressed first spring 9 acts, which appliesor presses a force via the engagement element 6 a on the dosing sleeve 5pushing it in the distal direction in order to prevent the productcontainer 13 being able to be displaced in the proximal directionrelative to the syringe holder 1. The product container 13 is held onits proximal end by a retaining spring section 5 c formed by the dosingsleeve 5 in engagement with the shoulder 1 b.

The product container 13 is arranged, relative to the housing 2, in sucha manner that the needle tip is distally beyond the distal end of thehousing 2. In the initial or delivery state of the autoinjector, i.e.,when the pull-off cap 4 is arranged on the autoinjector, the needle 13 ais formed by a needle cover cap 14, which is referred to in the depictedexample as a so-called rigid needle shield known to the person skilledin the art and alternatively referred to as soft needle shield, in orderto protect the needle 13 a against soiling or in order to keep theneedle 13 a and the medication sterile. The rigid needle shield 14 isarranged on a needle retaining section of the syringe body, wherein thetapering section of the syringe body is located between the needleretaining section and the cylindrical section of the syringe body. Theshoulder 1 b is arranged between the syringe body and the proximal endof the rigid needle shield 14, in particular in such a manner that,between the rigid needle shield 14 and the shoulder 1 b, a gap—albeit asmall gap—is provided in order to prevent the shoulder 1 b exerting aforce on the rigid needle shield 14, whereby, for example, the sterilityof the needle 13 a or of the fluid product could be impaired. Thepull-off cap 4 is detachably connected by snap connection to the housing2 or a needle protection sleeve 3, wherein this snap connection isreleased, when the pull-off cap 4 is removed from the housing 2 or theneedle protection sleeve 3. The pull-off cap 4 moreover comprises, inparticular, on a flexible arm, at least one catch 4 b, which engages ina gap between the syringe body, in particular its tapering area, and theproximal end of the rigid needle shield 14. When the pull-off cap 4 isremoved from the autoinjector, the catch 4 b hooks into the proximal endof the rigid needle shield 14, as a result of which the rigid needleshield 14 is detached from the product container 13 and removed togetherwith the cover cap 4 from the autoinjector (FIGS. 14a, 14b ).

The autoinjector has a needle protection sleeve 3, which is displaceablerelative to the housing 2 and along the longitudinal axis L by anactuation stroke H_(B) (FIG. 19a ) in the proximal direction into anactuated position, in order to trigger a product discharge. In theinitial position of the needle protection sleeve 3, as shown in FIGS.14a to 18b , wherein the pull-off cap 4 is removed, the distal end ofthe needle protection sleeve 3 is distally beyond the needle tip of theneedle 13 a, so that access to the needle tip is at first prevented. Bydisplacing the needle protection sleeve 3 by the actuation stroke H_(B),the needle protection sleeve 3 is displaced in the proximal directionuntil the needle 13 a protrudes from the distal end of the needleprotection sleeve 3, in particular over a length that corresponds to theinjection depth of the needle into the injection site. Preferably, theneedle 13 a should protrude beyond the distal end of the needleprotection sleeve 3 by a distance such that a subcutaneous injection canoccur. In particular, the housing 2 can form an abutment, with which theneedle protection sleeve 3 is in contact in the actuated position.

After the injection has taken place, the needle protection sleeve 3 canbe displaced, relative to the housing 2, from the actuated positionalong the longitudinal axis L by a needle protection stroke H_(N) in thedistal direction into a needle protection position (FIG. 22). In theneedle protection position, the distal end of the needle protectionsleeve 3 extends distally beyond the needle tip, so that access to theneedle tip is prevented and the risk of injury is reduced. As describedfurther below, the needle protection sleeve 3 can be blocked againstbeing pushed back again out of the needle protection position.

The syringe holder 1 has a bevel 1 a facing radially outward, whereinthe beveling 1 a engages in in a slit-shaped recess of the needleprotection sleeve 3, which is arranged between the housing 2 and thesyringe holder 1. In the initial position of the needle protectionsleeve 3 (FIGS. 14a to 18b ) and/or in the needle protection position ofthe needle protection sleeve 3 (FIG. 22), the needle protection sleeve3, in particular the proximal end of the slit-shaped recess, is incontact with the bevel 1 a, whereby a movement of the needle protectionsleeve 3 in the distal direction is prevented. Into this slit-shapedrecess, alternatively in another recess of the needle protection sleeve3, a cam 1 c, arranged resiliently on the syringe holder 1 and formed bythe syringe holder 1 can engage. The cam 1 c is designed so that, whenan attempt is made to displace the needle protection sleeve 3 from theinitial position into the actuated position, the cam 1 c at firstprevents the displacement of the needle protection sleeve 3, wherein thecam 1 c is pressed out, when the force exerted on the needle protectionsleeve 3 for pushing back exceeds a certain threshold value, whereby theneedle protection sleeve 3 is abruptly pushed back into the actuatedposition. As a result, the needle 13 a can be inserted abruptly into theinsertion site. In order to insert the needle 13 a or in order todisplace the needle protection sleeve 3 into the actuated position, thedistal end of the needle protection sleeve 3 is placed on the insertionsite, wherein the housing 2 is then pressed in the direction of theinsertion site, wherein, when the compressive force exceeds theabove-mentioned threshold value, the housing 2 is displaced abruptlytoward the insertion site, and the needle protection sleeve 3 isdisplaced relative to the housing 2 by the actuation stroke H_(B) intothe actuated position.

The autoinjector comprises a sleeve-shaped plunger rod 7 which forms, atits distal end, an inward protruding shoulder, against which a firstspring 9 is braced, which can also be referred to as a discharge spring.The first spring 9 is arranged within the sleeve-shaped plunger rod 7.The first spring 9 is a compression spring acting as a coil spring thatis sufficiently prestressed with energy in the initial or delivery stateof the autoinjector, so that the product contained in the productcontainer 13 can be discharged, in particular completely, by thedisplacement of the plunger rod 7 by a discharge stroke H_(A) from theproduct container 13. In the delivery state of the device, i.e., beforea priming, there is a distance between the piston 13 b and the distalend of the plunger rod 7, so that the plunger rod 7 strikes the piston13 b only during the performance of the priming stroke H_(P), entrainingsaid piston in the discharge direction. The first spring 9 is bracedwith its proximal end against a coupling sleeve 22, which is rotatableand axially fixed relative to the housing 2 and which is connected, inparticular engaged, in a rotatable and axially fixed manner to the dosesetting element 16.

The first engagement element 6 a of the dosing sleeve 5 engages in arecess 7 a, which is formed by the plunger rod 7. The recess 7 a has afirst abutment surface 7 c and a second annular abutment surface 7 dextending peripherally over the periphery of the plunger rod 7, theabutment surfaces being arranged with mutual angular offset along thelongitudinal axis L, in particular with a distance correspondingapproximately to the priming stroke H_(P) (FIG. 15). The recess 7 acomprises, in particular, a channel extending along the longitudinalaxis L, which connects the first abutment surface 7 c to the secondabutment surface 7 d of the plunger rod 7. In the delivery state of theautoinjector or before performing a priming, the engagement element 6 aof the dosing sleeve 5 is in contact with the first abutment surface 7 cof the plunger rod 7, as a result of which a movement of the plunger rod7 in the distal direction is blocked. A locking sleeve 8, which can bedisplaced along the longitudinal axis L, in particular a retainingsurface 8 d formed by said locking sleeve 8, retains the firstengagement element 6 a of the dosing sleeve 5 in the engagement with therecess 7 a of the plunger rod 7, in particular by blocking a movement ofthe first engagement member 6 a transversely to the longitudinal axis L.The locking sleeve 8, in particular its retaining surface 8 d, can bedisplaced from this position in the proximal direction into a positionin which the locking sleeve 8, in particular its retaining surface 8 d,releases the first engagement element 6 a for a movement transverse tothe longitudinal axis L.

By turning the dose setting element 16, the plunger rod 7 can be rotatedrelative to the dosing sleeve 5, as a result of which the first abutmentsurface 7 c can be turned out of contact with the engagement element 6 aof the dosing sleeve 5, as a result of which the plunger rod 7 can bedisplaced by means of the prestressed first spring 9 by the primingstroke H_(P) in the distal direction, wherein the engagement element 6 aof the dosing sleeve 5 is held during the priming stroke H_(P) in therecess 7 a, wherein, at the end of the priming stroke H_(P), theengagement element 6 a is in contact with the second abutment surface 7d, as a result of which the movement of the plunger rod 7 in the distaldirection is blocked, in particular blocked until the product dose isset and its discharge has been started.

For the product discharge, the locking sleeve 8 can be displaced in theproximal direction, whereby its retaining surface 8 d releases theengagement element 6 a of the dosing sleeve 5 from the recess 7 a or theengagement with the second abutment surface 7 d, whereby the plunger rod7 can be displaced by the first spring 9 in the distal direction or thedisplacement is released.

The plunger rod 7 comprises, on its outer periphery, a dose selectionabutment 100 in the form of a protrusion. The dosing sleeve 5 comprises,distributed over its periphery, namely at least a first dosing abutment110 (FIG. 12) and a second dosing abutment 111 (FIG. 12), which areangularly offset with respect to one another about the longitudinal axisL and arranged along the longitudinal axis L in different axialpositions.

The autoinjector comprises a sleeve-shaped displacement unit 11, whichis mounted in a rotationally fixed and axially displaceable manner onthe dosing sleeve 5. The displacement unit 11 comprises, on its innerperiphery, several entrainment abutments 11 e, wherein, with each dosingabutment 110, 111 of the dosing sleeve 5, one of these entrainmentabutments 11 e is associated, wherein the respective entrainmentabutment 11 e, in relation to the dosing abutment 110, 111 with which itis associated, is prepositioned in proximal direction and positioned sothat it is entrained by the dose selection abutment 100 of the plungerrod 7, when its dose abutment 110, 111 is in alignment with the doseselection abutment 100 and when the dose selection abutment 100 is movedtoward the dosing abutment 110, 111. As a result, the displacement unit11 is displaced in the distal direction, in particular toward the end ofthe discharge stroke H_(A).

The autoinjector comprises a ring 21, which is rotatable about thelongitudinal axis L and which surrounds the dosing sleeve 5. The ring 21can be moved from a first position, in which it can be turned relativeto the dosing sleeve 5 and is axially fixed at least in the proximaldirection, into a second position, in which it is rotationally fixedrelative to the dosing sleeve 5. The ring 21 comprises a protrusion,which is in contact with the shoulder of the dosing sleeve 5, whereinthe shoulder blocks the movement of the ring 21 in the proximaldirection and enables a turning of the ring 21. The ring 21 comprises agroove extending along the longitudinal axis L, into which theprotrusion of the ring 21 can be turned with a turning axial movement,and which holds the protrusion of the ring by both sides, so that arotation of the ring 21 relative to the dosing sleeve 5 is blocked.

The ring 21 is exposed to a force acting in the distal direction bymeans of a third prestressed spring 20, which is braced with itsproximal end against the ring 21 and with its distal end against thedosing sleeve 5. When the ring 21 is turned out of the first position,i.e., out of the axially fixed engagement with the shoulder, the thirdspring 20 presses the ring 21 in the proximal direction, as a result ofwhich the protrusion of the ring 21 is moved into the groove.

The displacement unit 11 comprises a transmission surface, which slideson a transmission counter-surface of the ring 21, when the displacementunit 11 is displaced in the distal direction, in particular toward theend of the product discharge, as a result of which the ring 21 is turnedfrom the first position and displaced by translation by the secondspring 20 into the second position.

The ring 21 can be accelerated or moved by the spring 20 against thecoupling sleeve 22, wherein, when the ring 21 strikes against thecoupling sleeve 22, a tactile and/or acoustic signal is generated, whichsignals the end of the discharge of the selected dose.

The ring 21 can be displaced by the spring 20 into a position, inparticular the second position, in which the ring 21 engages in arotationally fixed manner in the coupling sleeve 22, wherein thecoupling sleeve 22 is coupled in a rotationally fixed manner to the dosesetting element 16, in particular in a rotationally fixed engagementwith said coupling sleeve, whereby the turning of the dose settingelement 16 relative to the housing 2 is blocked.

The coupling sleeve 22 is coupled in a rotationally fixed manner to theplunger rod 7 via a detachable coupling engagement, at least before thetriggering of the product discharge, i.e., when the engagement element 6a of the dosing sleeve 5 is in contact with the first abutment surface 7c and/or the second abutment surface 7 d of the plunger rod 7. As aresult, the plunger rod 7 can also be rotated along with the dosesetting element 16 for the setting of the dose to be discharged. Forthis purpose, the proximal end of the plunger rod 7, in particular theprotrusion with the dose selection abutment 100, and the coupling sleeve22 engage in a rotationally fixed manner into one another. The couplingengagement can be released by means of a movement of the plunger rod 7in the distal direction, i.e., in particular by means of the dischargestroke H_(A), wherein the plunger rod 7 is displaced out of theengagement with the coupling sleeve 22 in the distal direction. When thecoupling engagement is released, i.e., during the discharge of the doseor when the dose selection abutment 100 of the plunger rod 7 is incontact with one of the dosing abutments 110, 111 of the dosing sleeve5, namely the selected dosing abutment, the dose setting element 16 andthe plunger rod 7 are rotationally uncoupled from one another.

For the administration of the medication, the pull-off cap 4 togetherwith the rigid needle shield 14 is removed from the autoinjector (FIG.14a ). Subsequently, the autoinjector is primed (FIG. 15) and the needleprotection sleeve 3 is released for a movement in the proximal direction(FIG. 16). The needle protection sleeve 3 is blocked in the initialposition from being displaced in the proximal direction. For thispurpose, the needle protection sleeve 3, in particular its proximal end,strikes against the switching sleeve 15, wherein the switching sleeve 15is blocked by a blocking abutment of the coupling sleeve 22 from beingmoved in the proximal direction.

After the removal of the pull-off cap 4, the dose setting element 16 isturned relative to the housing 2. The plunger rod 7 is connected in arotationally fixed manner, in particular via the coupling sleeve 22, tothe dose setting element 16.

By turning the dose setting element 16, the coupling sleeve 22, inparticular, is also turned, wherein the coupling sleeve 22 is turnedrelative to the switching sleeve 15, so that the blocking abutment ofthe coupling sleeve 22 is turned out of the engagement with theswitching sleeve 15. As a result, the switching sleeve 15 can be turnedpast the blocking abutment in the proximal direction.

Due to the turning of the dose setting element 16, the plunger rod 7, inparticular, is turned relative to the dosing sleeve 5, as a result ofwhich the engagement element 6 a of the dosing sleeve 5 is turned out ofcontact with the first abutment surface 7 c, so that the plunger rod 7is moved by means of the prestressed spring 9, by the priming strokeH_(P) in the distal direction, until the second abutment surface 7 d ofthe plunger rod 7 abuts against the engagement element 6 a of the dosingsleeve 5 and blocks the movement of the plunger rod 7 (FIG. 17).

Now the dose setting can occur (FIG. 18). For this purpose, the dosesetting element 16 is turned into one of the several rotationalpositions such as, for example, the first or second rotational positionrelative to the housing 2. The plunger rod 7, the coupling sleeve 22 andthe first spring 9 also turn with the dose setting element 16. Inparticular, by means of the turning of the dose setting element 16, thedose setting abutment 100 of the plunger rod 7 is turned relative to thefirst and second dosing abutments 110, 111 of the dosing sleeve 5, andthe entrainment abutments 11 e of the displacement unit 11. In the firstrotational position of the dose setting element 16, the dose selectionabutment 100 and the first dosing abutment 110 and the prepositionedentrainment abutment 11 e associated with the first dosing abutment 110are arranged in an alignment along the longitudinal axis L. In thesecond rotational position of the dose setting element 16, the doseselection abutment 100 is angularly offset about the longitudinal axis Ltoward the first dosing abutment 110 and in alignment with the seconddosing abutment 111 and the prepositioned entrainment abutment 11 eassociated with the second dosing abutment 111.

In order to trigger the administration of the set product dose, i.e., inorder to release the engagement of the first engagement element 6 a fromthe recess 7 a of the plunger rod 7, the needle protection sleeve 3 isdisplaced by the actuation stroke H_(B) in the proximal direction intothe housing 2. As a result, the proximal end 3 a of the needleprotection sleeve 3 entrains the switching sleeve 15, during a first andsecond partial stroke, into which the actuation stroke H_(B) issubdivided.

The locking sleeve 8 comprises a catch 8 e, which engages, in theinitial position of the needle protection sleeve 3, in an axially fixedmanner in the coupling sleeve 22, in particular in a first lock-inrecess. The catch 8 e can be moved transversely to the longitudinal axisL from the first lock-in recess, but it is prevented by a retainingsurface of the switching sleeve 15 from moving out of the first lock-inrecess (FIGS. 14b , 16).

During the first partial stroke, the switching sleeve 15 is movedrelative to the locking sleeve 8 and the coupling sleeve 22, whereby arecess 15 a is moved relative to the longitudinal axis L into theposition of the catch 8 e of the locking sleeve 8, so that the lateralblocking of the catch 8 e is released. During the second partial stroke,the needle protection sleeve 3 also entrains the locking sleeve 8. Thelocking sleeve 8 moves in the proximal direction relative to thecoupling sleeve 22. An abutment 3 c of the needle protection sleeve 3strikes against a locking member 8 a of the locking sleeve 8 andentrains the locking sleeve 8. The catch 8 e of the locking sleeve 8 isdisengaged from the first lock-in recess and engaged in a second lock-inrecess of the coupling sleeve 22. As a result, a locking of the needleprotection sleeve 3 is arranged. During the actuation stroke H_(B), asecond spring 10, in particular a needle protection spring is stressed.

Due to the movement of the locking sleeve 8 in the proximal direction,the retaining surface 8 d is displaced along the longitudinal axis L outof the lateral position, in which it blocks the movement of theengagement element 6 a of the dosing sleeve 5 out of the recess 7 a ofthe plunger rod 7. Thereby, the prestressed discharge spring 9 candisplace the plunger rod 7 by the discharge stroke H_(A) in the distaldirection. The engagement element 6 a is pressed out of the engagementwith the recess 7 a with a movement transverse to the longitudinal axisL (FIG. 19a ).

During the discharge stroke H_(A), the plunger rod 7 is displaced in thedistal direction until the rotationally fixed engagement between plungerrod 7 and coupling unit 22 is released.

The dose selection abutment 100 of the plunger rod 7 is moved toward thesecond dosing abutment 111, wherein the dose selection abutment 100,toward the end of the discharge stroke H_(A), entrains the entrainmentabutment 11 e of the displacement unit 11 which is prepositioned andassociated with the second dosing abutment 111, at least over a distancesuch that the displacement unit 11 is displaced relative to the dosingsleeve 5 in the distal direction, until the dose selection abutment 100strikes the second dosing abutment 111, whereby the movement of theplunger rod 7 in the distal direction is blocked. During the dischargestroke H_(A), the dose selection abutment 100 of the plunger rod 7 ismoved past the first dosing abutment 110.

Due to the movement of the displacement unit 11 in the distal direction,it slides on the ring 21 and turns it out of its first position (FIG.20), as a result of which the ring 21 is pressed by the spring 20 intoits second position, and, in the process, on the one hand, a signal isgenerated and, on the other hand, a coupling sleeve 22 is coupled in arotationally fixed manner to the dosing sleeve 5, as a result of whichthe dose setting element 16 is rotationally fixed relative to thehousing 2 and thus a dose setting can no longer be carried out (FIG.21).

When the autoinjector is removed from the insertion site, the secondspring 10 displaces the switching sleeve 15 relative to the housing 2and/or the locking sleeve 8 in the distal direction, wherein theswitching sleeve 15 displaces the needle protection sleeve 3 in thedistal direction by the needle protection stroke H_(N), whereby thelocking member 8 a of the locking sleeve 8 is engaged in the switchingsleeve 15, in particular the recess 15 a, and the switching sleeve 15blocks the disengagement of the catch 8 e of the locking sleeve 8 fromthe second lock-in recess of the coupling sleeve 22.

Due to the engagement of the locking member 8 a of the locking sleeve 8in the recess 15 a of the switching sleeve 15 and the engagement of thecatch 8 e of the locking sleeve 8 in the coupling sleeve 22, the lockingsleeve 8 and the switching sleeve 15 are prevented from moving in thedistal direction, so that, when an attempt is made to displace theneedle protection sleeve 3 in the proximal direction, this movement isblocked.

Third Embodiment

In reference to FIGS. 23 to 32 b, the structural features and thefunction of the autoinjector according to the third embodiment are nowdescribed.

The autoinjector comprises a sleeve-shaped, elongate housing 2 with alongitudinal axis L, which, at its proximal end, comprises asleeve-shaped housing insert or rotation sleeve 12, which is connectedwith positive connection to the housing 2 in a rotational and axiallyfixed manner and which is arranged on the proximal end of the housing 2.The rotation sleeve 12 is snapped by means of a protrusion 12 a with asnap into a recess 2 a of the housing 2, so that it is rotatable andaxially fixed relative to the housing 2 and, in particular, so that itcannot be removed from the housing 2, or so that it cannot be removed ina simple way. The rotation sleeve 12 comprises a lock-in catch 12 c. Thehousing 2 comprises several, in particular at least two, lock-in grooves2 f distributed over the periphery, wherein the lock-in catch 12 cengages in one of the lock-in grooves 2 f and, when the rotation sleeve12 is turned, such as, for example, for a dose setting, is moved out ofthe lock-in groove 2 f and moved into another of the lock-in grooves 2 fAs a result, quasi-stable lock-in positions are specified for therotation sleeve 12, and a dose setting element 16 connected inrotationally fixed manner to the rotation sleeve 12 is specified.

The sleeve-shaped dose setting element 16 is connected on the proximalend of the housing 2 rotatably and in an axially fixed manner to thehousing, forming, in particular, the proximal end of the autoinjector.The dose setting element 16 can be gripped by the user of the device andturned relative to the housing 2 for the setting of a product dose to bedischarged. For example, it is possible to set two different doses to bedischarged, such as, for example, 0.25 and 0.5 mL. Alternatively, thelock-in catch 12 c can be arranged on the dose setting element 16. Forexample, the dose setting element 16 can assume, relative to the housing2, at least three different quasi-stable rotational positions, whereinno dose can be set in an initial position, a first dose can be set in afirst position, and a second dose can be set in a second position, etc.

On the distal end of the autoinjector, in its delivery state (FIGS.24a-24c ), a pull-off cap 4 is arranged, which is pulled or twisted offbefore the use of the autoinjector, and removed.

In the housing 2, a product container 13, in the form of a syringe, isaccommodated non-displaceably relative to the housing 2—except for theinstallation of the autoinjector—along the longitudinal axis L. Theproduct container 13 comprises a sleeve-shaped syringe body thatsurrounds a piston 13 b and is in sealing contact with the innerperiphery of the syringe body. On its distal end, the syringe bodycomprises, in particular, an injection needle 13 a, which is connecteddetachably to the syringe body and whose distal end is formed by theneedle tip. Between the injection needle 13 a and the piston 13 b, afluid product, in particular medication, is arranged within the syringebody, wherein the displacement of the piston 13 b in a dischargedirection, i.e., in the distal direction or toward the injection needle13 a, causes the discharge of the product through the hollow injectionneedle 13 a from the product container 13. On its proximal end, thesyringe body comprises a so-called finger flange, which protrudesradially outward over the periphery of the cylindrical syringe body. Theproduct container 13 is accommodated in a product container holder 1,referred to below as syringe holder 1, in such a manner that it isprotected at least against movement along the longitudinal axis L in thedistal direction relative to the syringe holder 1. As can be seen inFIG. 24a , for example, the syringe holder 1 is connected by positiveconnection to the housing 2. For this purpose, the housing 2 hasrecesses into which the lock-in elements, formed here on the proximalend of the syringe holder 1, engage. The syringe holder 1 has at leastone inward protruding shoulder 1 b, against which is braced a taperingsection of the product container 13, which is arranged distally withrespect to the cylindrical syringe body section, which guides the piston13 b.

The autoinjector comprises a dosing sleeve 5, which is arranged in thehousing 2 and which is snapped to the housing 2 or to a sleeve-shapedhousing insert in a manner so that it is rotatable and preferablyaxially fixed relative to the housing 2 and a plunger rod 7, inparticular in a manner so that it is axially fixed to the housing or tothe sleeve-shaped housing insert.

In order to prevent the product container 13 from being able to bedisplaced relative to the syringe holder 1, the product container 13 ispressed at its proximal end by a retaining spring section 5 c, whichacts via a rotation prevention sleeve 18 on the syringe body, intoengagement with a shoulder 1 b. Due to the retaining spring section 5 c,length differences of the product container 13, which can occur due tomanufacturing tolerances, can be compensated, wherein the firm seatingof the product container 13 on the shoulder 1 b is ensured.

The product container 13 is arranged, relative to the housing 2, in sucha manner that the needle tip extends distally beyond the distal end ofthe housing 2. In the initial or delivery state of the autoinjector,i.e., when the pull-off cap 4 is arranged on the autoinjector, theneedle 13 a is formed by a needle protection cap 14 which, in thedepicted example, is referred to as a so-called rigid needle shieldknown to the person skilled in the art, alternatively known as a softneedle shield, in order to protect the needle 13 a against soiling or tokeep the needle 13 a and the medication sterile. The rigid needle shield14 is arranged on a needle holder section of the syringe body, whereinthe tapering section of the syringe body is located between the needleholder section and the cylindrical section of the syringe body. Theshoulder 1 b is arranged between the syringe body and the proximal endof the rigid needle shield 14, in particular so that between the rigidneedle shield 14 and the shoulder 1 b, a gap—albeit a small gap—isproduced in order to prevent the shoulder 1 b exerting a force on therigid needle shield 14, whereby, for example, the sterility of theneedle 13 a and of the fluid product could be impaired. The pull-off cap4 is snapped detachably to the housing 2 or a needle protection sleeve3, wherein this snap connection is loosened, when the pull-off cap 4 isremoved from the housing 2 or the needle protection sleeve 3. Thepull-off cap 4 moreover comprises, in particular on a flexible arm, atleast one catch 4 b, which engages in a gap between the syringe body, inparticular its tapering area, and the proximal end of the rigid needleshield 14. When the pull-off cap 4 is removed from the autoinjector, thecatch 4 b hooks into the proximal end of the rigid needle shield 14, asa result of which the rigid needle shield 14 is detached from theproduct container 13 and removed together with the cover cap 4 from theautoinjector (FIG. 25).

The autoinjector has a needle protection sleeve 3, which is displaceablerelative to the housing 2 and along the longitudinal axis L by anactuation stroke H_(B) in the proximal direction into an actuatedposition, in order to trigger a product discharge. In the initialposition of the needle protection sleeve 3 as shown in FIGS. 26a-26b ,wherein the pull-off cap 4 is removed, the distal end of the needleprotection sleeve 3 is distally beyond the needle tip of the needle 13a, so that access to the needle tip is at first prevented. A catch 3 bon the needle protection sleeve 3 is engaged in a recess 2 b of thehousing 2. By displacing the needle protection sleeve 3 (FIGS. 26b-27a )by the actuation stroke H_(B), the catch 3 b is pressed out of therecess 2 b of the housing 2, and the needle protection sleeve 3 isdisplaced in the proximal direction until the needle 13 a protrudes fromthe distal end of the needle protection sleeve 3, in particular over alength that corresponds to the injection depth of the needle into theinjection site. Preferably, the needle 13 a should protrude beyond thedistal end of the needle protection sleeve 3 by a distance such that asubcutaneous injection can occur. In particular, the housing 2 can forman abutment with which the needle protection sleeve 3 is in contact inthe actuated position.

After the injection has taken place, the needle protection sleeve 3 canbe displaced, relative to the housing 2, from the actuated positionalong the longitudinal axis L by a needle protection stroke H_(N) in thedistal direction into a needle protection position (FIGS. 32a-32b ). Inthe needle protection position, the distal end of the needle protectionsleeve 3 extends distally beyond the needle tip, so that access to theneedle tip is prevented and the risk of injury is reduced. As describedfurther below, the needle protection sleeve 3 can be blocked againstbeing pushed back again out of the needle protection position.

The syringe holder 1 has a bevel 1 a facing radially outward, whereinthe bevel 1 a engages in a slit-shaped recess of the needle protectionsleeve 3, which is arranged between the housing 2 and the syringe holder1. In the initial position of the needle protection sleeve 3 (FIGS.24a-24c ) and/or in the needle protection position of the needleprotection sleeve 3 (FIGS. 32a-32b ), the needle protection sleeve 3, inparticular the proximal end of the slit-shaped recess, is in contactwith the bevel 1 a, whereby a movement of the needle protection sleeve 3in the distal direction is prevented. Into this slit-shaped recess,alternatively into another recess of the needle protection sleeve 3, acam, which is arranged resiliently on the syringe holder 1 and formed bythe syringe holder 1, can engage. The catch 3 b on the needle protectionsleeve 3 is engaged in the recess 2 b of the housing, in such a mannerthat, when an attempt is made to displace the needle protection sleeve 3from the initial position into the actuated position, the catch 3 b atfirst prevents the displacement of the needle protection sleeve 3,wherein the catch 3 b is pressed out of the recess 2 b, when the forceexerted on the needle protection sleeve 3 in order to push it backexceeds a certain threshold value, as a result of which the needleprotection sleeve 3 is pushed back abruptly into the actuated position(FIGS. 26b-27a ). As a result, the needle 13 a can be inserted abruptlyinto the insertion site. In order to insert the needle 13 a or in orderto displace the needle protection sleeve 3 into the actuation position,the distal end of the needle protection sleeve 3 is placed on theinsertion site, wherein the housing 2 is then pressed in the directionof the insertion site, wherein, when the compressive force exceeds theabove-mentioned threshold value, the housing 2 is displaced abruptlytoward the insertion site, and the needle protection sleeve 3 isdisplaced relative to the housing 2 by the actuation stroke H_(B) intothe actuated position.

The autoinjector moreover comprises a sleeve-shaped plunger rod 7, whichforms an inward protruding shoulder, against which a first spring 9 isbraced, which can also be referred to as a discharge spring. The firstspring 9 is arranged within the sleeve-shaped plunger rod 7. The firstspring 9 is a compression spring acting as a coil spring, which issufficiently prestressed with energy in the initial or delivery state ofthe autoinjector, so that the product contained in the product container13 can be discharged, in particular completely, by the displacement ofthe plunger rod 7 by a discharge stroke H_(A) from the product container13. In the delivery state of the device, there is a distance between thepiston 13 b and the distal end of the plunger rod 7, so that the plungerrod 7 strikes the piston 13 b only at the time of the performance of thedischarge stroke H_(A), entraining said piston in the dischargedirection.

The first spring 9 is braced with its proximal end against a retainingelement 6, which, in this example, has two arms 6 c, wherein, on eacharm 6 c, a first engagement element 6 a and a second engagement element6 b are arranged. The first engagement element 6 a faces radiallytowards the longitudinal axis L, wherein the second engagement element 6b faces radially away from the longitudinal axis L. The first engagementelement 6 a engages in a first recess 7 a formed by the plunger rod 7,whereby a movement of the plunger rod 7 relative to the retainingelement 6 in the distal direction or in the discharge direction isprevented. As a result, the first spring 9 is retained in its stressedstate. Within the first spring 9, a guide pin 6 d is arranged, which isinserted through the proximal end of the of the first spring 9 into thecore of the spring 9, and which comprises, on its proximal end, a headagainst which the first spring 9 is braced with its proximal end. Thehead of the guide pin 6 d lies loosely against the retaining element 6,so that the retaining element 6 can be turned relative to the guide pin6 d. The guide pin 6 d prevents a lateral deflection of the first spring9 during and at the end of the discharge stroke H_(A) of the plunger rod7.

The autoinjector comprises a switching module 8, 15, which comprises aswitching sleeve 15 and a locking sleeve 8 surrounded by the switchingsleeve 15. In the delivery state of the device, the first engagementelement 6 a of the retaining element 6 is retained by the innerperiphery of the locking sleeve 8, which is in contact with the secondengagement element 6 b of the retaining element 6, in the engagementwith the first recess 7 a of the plunger rod 7.

The switching sleeve 15 is connected to the proximal end 3 a of theneedle protection sleeve 3 or is at least in contact with the proximalend 3 a of the needle protection sleeve 3. A second spring 10, withinwhich the first spring 9 is arranged and which preferably at leastpartially surrounds the switching sleeve 15 and the locking sleeve 8, isbraced with its distal end against the switching sleeve 15. Part of theswitching sleeve 15 is thus arranged between the needle protectionsleeve 3 and the distal end of the second spring 10. The second spring10 is a spring made of metal acting as a compression spring and designedas a coil spring. The second spring 10 is braced with its proximal endagainst a displacement unit 11, in particular against a protrusion 11 c,which engages in an axially displaceable and rotationally fixed mannerin the dosing sleeve 5, in particular through a slit-shaped groove 5 bof the dosing sleeve 5. The second spring 10 thus also surrounds thedosing sleeve 5 at least partially, preferably completely.

The switching sleeve 15 comprises a recess 15 a, into which a lockingmember 8 a of the locking sleeve 8 engages. The locking member 8 a issaw tooth-shaped and protrudes radially away from the longitudinal axisL. The locking member 8 a is resiliently arranged on an arm, which isformed by the locking sleeve 8. Due to the displacement of the switchingsleeve 15 in the proximal direction, the locking sleeve 8 is entrainedvia the engagement of the locking member 8 a in the proximal direction.

By displacing the needle protection sleeve 3 into the actuated position,the switching sleeve 15 is also entrained by the actuation stroke H_(B),as a result of which the second spring 10 is stressed. If the needleprotection sleeve 3 is not displaced completely into the actuatedposition, the second spring 10 can displace the switching sleeve 15 andthe needle protection sleeve 3 back again into the initial position,wherein, via the engagement of the locking member 8 a, the lockingsleeve 8 is also entrained by the switching sleeve 15. The displacementunit 11, which is in particular sleeve-shaped, in the delivery state orbefore the triggering of the product discharge, is in an axially fixedengagement with the plunger rod 7. The displacement unit 11 comprises afirst engagement unit 11 a, which engages in a recess 7 b of the plungerrod 7, as well as a second engagement element 11 b. The first engagementelement 11 a and the second engagement element 11 b are resilientlyarranged on the end of an arm 11 d of the displacement unit 11. Thedisplacement unit 11 comprises two such arms 11 d with a firstengagement element 11 a and a second engagement element 11 b. The firstengagement element 11 a faces radially toward the longitudinal axis L,wherein the second engagement element 11 b faces radially away from thelongitudinal axis L. In the delivery state, the first engagement element11 a is retained by the inner periphery of the locking sleeve 8 in theaxially fixed engagement with the plunger rod 7. The second engagementelement 11 b is in contact with the inner periphery of the lockingsleeve 8. The rotation sleeve 12 comprises a signal abutment 12 b,against which the displacement unit 11 can strike in order to generate asignal and which is preferably in contact with the displacement unit 11in the delivery state of the device.

The rotation prevention sleeve 18, which is preferably displaceablealong the longitudinal axis L, connects the housing 2 and the plungerrod 7 in a rotationally fixed manner, wherein the plunger rod 7 isdisplaceable relative to the rotation prevention sleeve 18 along thelongitudinal axis L. The plunger rod 7, on its outer periphery,comprises a first dosing abutment 110 and optionally a retainingabutment 112.

At least the dose setting element 16 and the dosing sleeve 5 areconnected in a rotationally fixed manner, so that a turning of the dosesetting element 16 produces a turning of the dosing sleeve 5. In thedepicted example, the dose setting element 16 is connected in arotationally fixed manner to the dosing sleeve 5, the displacement unit11, the retaining element 6, the switching sleeve 15, the locking sleeve8 and the second spring 10, so that a turning of the dose setting device16 produces a turning of the dosing sleeve 5, the displacement unit 11,the retaining element 6, the switching sleeve 15, the locking sleeve 8and the second spring 10.

The dosing sleeve 5, particularly a retaining section 5 g forming thedistal end of the dosing sleeve 5 and that is resiliently connected, ina manner so as to form a single part, via the retaining spring section 5c to a main section 5 f of the dosing sleeve 5, comprises a doseselection abutment 100. In the initial position, at least when no dosecan be set by means of the dose setting element 16, the optionallypresent retaining abutment 112 can be in contact with the dose selectionabutment 100, in order to remove the force of the prestressed firstspring 9 from the discharge mechanism of the autoinjector during longerstorage periods.

By turning the dose setting element 16 for the setting of the productdose to be administered, the dose setting abutment 100 of the dosingsleeve 5 can be turned relative to the first dosing abutment and theoptionally present retaining abutment 112 about the longitudinal axis L.

In the initial position of the autoinjector, a catch 3 b of the needleprotection sleeve 3 engages in a recess of the housing 2 (FIG. 24b ).The switching sleeve 15 has a retaining surface 15 b, which is arranged,relative to the catch 3 b, in such a manner that it prevents the catch 3b from moving out of the recess. In order to be able to displace theneedle protection sleeve 3 into the proximal direction, it is necessaryto release the blocking of the movement out of the recess of the housing2 and enable movement of the catch 3 b out of the recess.

In order to administer the product from the product container 13, thepull-off cap 4 together with the rigid needle shield 14 (FIG. 25) isremoved from the autoinjector. Subsequently or before, by turning thedose setting element 16 relative to the housing, a dose to be dischargedis set. By turning the dose setting element 16 out of the initialposition, in which the retaining abutment 112 is in contact with thedose selection abutment 100, into a first rotational position for afirst dose and into a second rotational position for a second dose, theretaining surface 15 b is turned relative to the catch 3 b of the needleprotection sleeve 3 into a position in which the catch 3 b can move outof the recess.

When the dose setting element 16 assumes its first rotational positionof the at least two rotational positions, the dose selection abutment100 is arranged in alignment along the longitudinal axis L with thefirst dosing abutment 110.

When the dose setting element 16 assumes its second rotational positionof the at least two rotational positions, the dose selection abutment100 is arranged with angular offset about the longitudinal axis L withrespect to the first dosing abutment 110.

The distal end of the needle protection sleeve 3 is placed on theinsertion site of a patient, where the housing 2 is displaced towardsthe insertion site, whereby the needle protection sleeve 3 is moved fromits initial position by the actuation stroke H_(B) in the proximaldirection relative to the housing 2 into the actuated position (FIGS.26a,b and 27 a,b). In the process, the catch 3 b of the needleprotection sleeve 3 is pressed out of the housing 2. The second spring10 is stressed, wherein the switching sleeve 15 is entrained by theneedle protection sleeve 3 by the actuation stroke H_(B). The lockingsleeve 8 comprises a first recess 8 b, which is moved, by displacementof the locking sleeve 8 by the actuation stroke H_(B) along thelongitudinal axis L, into the position of the second engagement element6 b of the retaining element 6, as represented in FIGS. 27a,b . Thereby,the first engagement element 6 a is moved out of the engagement with theplunger rod 7 with a movement transverse to and away from thelongitudinal axis L, wherein, at the same time, the second engagementelement 6 b of the retaining element 6 is moved into the engagement withthe locking sleeve 8, in particular its first recess 8 b. As a result,the plunger rod 7 is released for the movement by the discharge strokeH_(A) in the discharge direction (FIG. 28), wherein the size of thedischarge stroke H_(A) depends on the rotational position of the dosesetting element 16.

When the dose setting element 16 is in its first rotational position,the first dosing abutment 110 of the plunger rod 7 is moved toward thedose selection abutment 100 of the dosing sleeve 5 until it strikesagainst the dose selection abutment 100, whereby the discharge movementof the plunger rod 7 is stopped and only a true partial quantity of theproduct in the product container 13 is expelled.

When the dose setting element 16 is in its second rotational position,the first dosing abutment 110 of the plunger rod 7, which is arrangedwith angular offset about the longitudinal axis L with respect to thedose selection abutment 100 of the dosing sleeve 5, is moved past thedose selection abutment 100 along the longitudinal axis L. In theprocess, the discharge stroke H_(A) is greater than in the firstrotational position of the dose setting element 16. In the depictedexample, the piston 13 b is displaced in the product container 13 untilit strikes against the tapering area of the syringe body, whereby thedischarge movement of the plunger rod 7 is stopped, and the entireproduct quantity contained in the product container 13 is expelled.Alternatively, a second dosing abutment (not shown) can be formed on theplunger rod 7 and be angularly offset with respect to the first dosingabutment 110 of the plunger rod 7 about the longitudinal axis L andarranged along the longitudinal axis L in another position, wherein, inthe second rotational position of the dose setting element 16, the doseselection abutment 100 of the dosing sleeve 5 is arranged in alignmentalong the longitudinal axis L with the second dosing abutment. Thesecond dosing abutment is then moved toward the dose selection abutment100 of the dosing sleeve 5 until it strikes against the dose selectionabutment 100, whereby the discharge movement of the plunger rod 7 isstopped and only a true partial quantity, which is greater than thepartial quantity when the dose setting element is in its firstrotational position, is expelled. Analogously to this alternative, in adevelopment, the dose setting element 16 can be turned into a thirdrotational position, in which a third dosing abutment of the plunger rod7 and the dose selection abutment 100 of the dosing sleeve 5 are inalignment, etc.

When the plunger rod 7 is released for the movement by the dischargestroke H_(A) into the discharge direction (FIG. 28), the axially fixedcoupling between the plunger rod 7 and the retaining element 6 iseliminated, whereby the retaining element 6, which can be moved over atleast a distance relative to the housing 2 and along the longitudinalaxis L, can be moved by the first spring 9 in the proximal direction,wherein the retaining element 6, via the engagement of the secondengagement element 6 b in the recess 8 b of the locking sleeve 8,entrains the locking sleeve 8 by a start signal stroke, whereby thelocking sleeve 8 strikes against a start signal abutment, which isformed by the dosing sleeve 5, and thereby issues an acoustic and/ortactile signal signaling to the user of the device that the productdischarge has started. By displacing the locking sleeve 8 by theactuation stroke H_(B), the locking member 8 a of the locking sleeve 8is released for a movement transverse to and toward the longitudinalaxis L, since the dosing sleeve 5 has a recess 5 d, which enables such amovement of the locking member 8 a of the locking sleeve 8 when thelocking sleeve 8 has been displaced by the actuation stroke H_(B) orwhen the needle protection sleeve 3 is in its actuated position (FIG.27b ).

Since the displacement unit 11 is still connected in an axially fixedmanner to the plunger rod 7, it is entrained by a first partial strokeof the discharge stroke H_(A) in the discharge direction, wherein thedisplacement unit 11 is moved by approximately the first partial strokeaway from the signal abutment 12 b, as can be seen best in FIG. 29. Atthe end of the first partial stroke, during which the first and secondengagement units 11 a, 11 b of the displacement unit 11 are movedrelative to the locking sleeve 8, the first engagement element 11 a ispressed out of the engagement with the plunger rod 7, wherein, at thesame time, the second engagement element 11 b is moved into the secondrecess 8 c of the locking sleeve 8 with a movement transverse to thelongitudinal axis L and radially away from the longitudinal axis L (FIG.29). As a result, the displacement unit 11 is prevented from moving inthe proximal direction relative to the housing 2 or the locking sleeve8. The second engagement unit 11 b is held by the outer periphery of theplunger rod 7 in the engagement with the recess 8 c of the lockingsleeve 8, when the plunger rod 7 is moved by a second partial stroke ofthe discharge stroke H_(A). The outer peripheral surface of the plungerrod 7 retains the second engagement element 6 b of the retaining element6 in the engagement with the first recess 8 b of the locking sleeve 8.At the end of the discharge stroke H_(A), the piston rod 7 releases thesecond engagement unit 11 b of the displacement unit 11 from theengagement with the locking sleeve 8, as a result of which the secondengagement unit 11 b is moved out of the engagement with the recess 8 c,in particular toward the longitudinal axis L, so that the second spring10 accelerates the displacement unit 11 against the discharge direction,i.e., in the proximal direction, so that, when the displacement unit 11strikes against the signal abutment 12 b, an acoustic and/or tactilesignal is generated. As can be seen best in FIG. 32a , the engagement ofthe second engagement element 6 b of the retaining element 6 in thefirst recess 8 b of the locking sleeve 8 continues to exist, as a resultof which a movement of the locking sleeve 8 in the distal directionrelative to the housing 2 is prevented.

By removing the autoinjector from the injection site, the second spring10 can move the switching sleeve 15 and the needle protection sleeve 3from the actuated position into the needle protection position by theneedle protection stroke H_(N), wherein the locking member 8 a of thelocking sleeve 8 is pressed out of the engagement with the recess 15 a,wherein the switching sleeve 15 is moved relative to the locking sleeve8 in the distal direction. When the needle protection sleeve 3 is in itsneedle protection position, the locking member 8 a snaps into theswitching sleeve 15, wherein the locking member 8 a prevents the needleprotection sleeve 3 from being pushed back into its actuated position.When an attempt is made to push the needle protection sleeve 3 from theneedle protection position back into the actuated position, theswitching member 15 strikes against the locking member 8 a of thelocking sleeve 8, which prevents the movement of the needle protectionsleeve 3 into the actuated position. For this purpose, the lockingsleeve 8 is braced axially against the start signal abutment of thedosing sleeve 5.

The invention claimed is:
 1. An autoinjector device for administering aliquid product, in particular medication, the autoinjector comprising: ahousing; a product container, at a distal end of which a needle isarranged and in which a piston is displaceably arranged, wherein theproduct container is retained in a product container holder, wherein theproduct container holder is connected to the housing in an axially fixedmanner, and wherein the needle protrudes beyond a distal end of thehousing; a needle protection sleeve, which is displaceable from aninitial position, in which a distal end of the needle protection sleeveis distally arranged beyond a needle tip of the needle, into the housingso that the needle protrudes from the distal end of the needleprotection sleeve; a plunger rod arranged in the housing anddisplaceable by a preloaded discharge spring along a longitudinal axisin a distal direction, wherein, as a result of a displacement of theplunger rod in the distal direction, the piston is entrained by theplunger rod and displaces the product from the product container; a dosesetting element which, in order to set a dose of the product to bedischarged from the product container, is rotatable in relation to thehousing and can assume at least two different rotational positions inrelation to the housing, wherein the rotational positions are lock-inpositions; and a dosing sleeve, wherein one of the dosing sleeve and theplunger rod comprises a dose selection abutment and the other of thedosing sleeve and the plunger rod comprises at least one dosingabutment, wherein, as a result of a rotation of the dose settingelement, one of the dosing sleeve and the plunger rod is rotated inrelation to the other of the dosing sleeve and the plunger rod, wherein,in a first rotational position of the at least two rotational positions,the dose selection abutment and a first dosing abutment of the at leastone dosing abutment are arranged in an alignment along the longitudinalaxis, wherein, in a second rotational position of the at least tworotational positions, the dose selection abutment is arranged angularlyoffset about the longitudinal axis in relation to the first dosingabutment, and wherein, as a result of a displacement of the needleprotection sleeve into the housing, the discharge spring displaces theplunger rod in the distal direction, whereby, when the dose settingelement is in the first rotational position thereof, one of the doseselection abutment and the first dosing abutment strikes against theother of the dose selection abutment and the first dosing abutment, andwhen the dose setting element is in the second rotational positionthereof, one of the dose selection abutment and the first dosingabutment is moved or is movable past the other of the dose selectionabutment and the first dosing abutment along the longitudinal axis. 2.The device of claim 1, wherein the dose setting element comprises arotary knob coupled to a proximal end of the housing and is grippable bya user of the device, wherein the dose setting element is axially fixedand rotatable in relation to the housing.
 3. The device of claim 1,further comprising a lock-in device for providing the lock-in positionsfor the dose setting element.
 4. The device of claim 1, wherein in thesecond rotational position of the at least two rotational positions, thedose selection abutment and a second dosing abutment of the at least onedosing abutment are arranged in an alignment along the longitudinalaxis, and wherein one of the dose selection abutment and the seconddosing abutment strikes against the other of the dose selection abutmentand the second dosing abutment when the dose setting element is in thesecond rotational position thereof, and the discharge spring displacesthe plunger rod in the distal direction.
 5. The device of claim 4,wherein the first dosing abutment and the second dosing abutment arespaced apart from one another along the longitudinal axis and arrangedangularly offset about the longitudinal axis.
 6. The device of claim 1,wherein the product container comprises an abutment against which thepiston strikes when the dose setting element is in the second rotationalposition thereof or in a third rotational position of the rotationalpositions thereof, and the discharge spring displaces the plunger rod inthe distal direction.
 7. The device of claim 1, wherein the plunger rodcomprises the dose selection abutment, wherein the dosing sleeve or apart of the device different from the dosing sleeve and the productcontainer comprises an abutment against which the dose selectionabutment of the plunger rod or an additional dose selection abutment ofthe plunger rod strikes when the dose setting element is in the secondrotational position thereof or in a third rotational position of therotational positions thereof, and the discharge spring displaces theplunger rod in the distal direction.
 8. The device of claim 1, whereinthe dose selection abutment is formed on the plunger rod, wherein the atleast one dosing abutment comprises a first dosing abutment and a seconddosing abutment, which are formed on the dosing sleeve, wherein thedosing sleeve is rotationally fixed in relation to the housing, andwherein the plunger rod is connected in a rotationally fixed manner tothe dose setting element and is rotatable together with the dose settingelement in relation to the housing and/or the dosing sleeve.
 9. Thedevice of claim 8, wherein the dosing sleeve comprises a stop abutment,the device further comprising a mechanism holder, which is arranged inan axially fixed, rotatable manner relative to the housing, andcomprises a stop counter-abutment, wherein the dose selection abutment,when the plunger rod is moved in the distal direction, strikes againstthe first or second dosing abutment and entrains the dosing sleeve inthe distal direction, whereby the stop abutment is moved towards thestop counter-abutment, wherein the movement of the plunger rod and thedosing sleeve in the distal direction is blocked when the stop abutmentstrikes against the stop counter-abutment.
 10. The device of claim 9,further comprising a displacement unit, wherein the displacement unitcomprises a first engagement unit, which engages in a recess of themechanism holder, such that the displacement unit is retained in anaxially fixed manner in relation to the housing, wherein the firstengagement unit is prevented by the dosing sleeve from moving out of therecess when the stop abutment is at a distance from the stopcounter-abutment, wherein, due to the entrainment of the dosing sleeveby the plunger rod, the dosing sleeve is moved out of the position inwhich the dosing sleeve prevents the first engagement unit from movingout of the recess.
 11. The device of claim 10, further comprising aneedle protection spring configured to move the displacement unitrelative to the housing in a proximal direction, wherein: during themovement in the proximal direction, the displacement unit strikesagainst a fixed part of the device and thereby generates a tactileand/or acoustic signal, which signals an end of a discharge of a setdose and/or the displacement unit, which is connected in a rotationallyfixed manner to the mechanism holder and to the dose setting element, ismoved by the movement in the proximal direction into a rotationallyfixed positive locking engagement with the housing or with an elementattached to the housing, so that the dose setting element isrotationally fixed in relation to the housing about the longitudinalaxis.
 12. The device of claim 10, further comprising a second engagementunit configured to detachably engage in a recess of the plunger rod forblocking the plunger rod against a movement relative to the housing inthe distal direction, wherein, in an initial position of the dosesetting element, a retaining surface of the housing or an element thatis attached to the housing prevents the second engagement unit frommoving out of the recess, and, in the first or second rotationalposition of the dose setting element, the retaining surface and thesecond engagement unit are spaced angularly offset about thelongitudinal axis, so that the second engagement unit is movable out ofthe recess of the plunger rod, and the plunger rod is movable in thedistal direction by the discharge spring in a priming stroke.
 13. Thedevice of claim 12, wherein at the end of the priming stroke, theplunger rod strikes against a first engagement element, which engages inthe recess of the plunger rod to block movement of the plunger rod inthe distal direction, wherein when the needle protection sleeve is movedinto the housing, the needle protection sleeve displaces a lockingsleeve from a position in which the locking sleeve prevents the firstengagement element from moving out of the recess of the plunger rod inthe proximal direction into a release position, wherein the lockingsleeve comprises a recess which, in the release position along thelongitudinal axis, coincides with a position of a second engagementelement of the retaining element, so that the second engagement elementis movable into the recess and at the same time the first engagementelement is movable out of the engagement with the plunger rod, wherebythe movement of the plunger rod in the distal direction is released fora discharge of a set dose.
 14. The device of claim 1, wherein the doseselection abutment is formed on the plunger rod, wherein the at leastone of the first dosing abutment and the second dosing abutment isformed on the dosing sleeve, wherein the dosing sleeve is rotationallyfixed in relation to the housing, wherein the plunger rod is connectedin a rotationally fixed manner to the dose setting element and isrotatable together with the dose setting element in relation to thehousing and/or the dosing sleeve, wherein the dosing sleeve either isconnected in an axially fixed manner to the housing, or is connecteddisplaceably to the housing, wherein the dosing sleeve is braced foraxial fixation on a proximal end of the product container.
 15. Thedevice of claim 14, wherein the dosing sleeve comprises an engagementelement configured to engage in a recess of the plunger rod, wherein therecess comprises a first abutment surface in contact with the engagementelement, whereby a movement of the plunger rod in the distal directionrelative to the housing and/or the dosing sleeve is blocked, wherein thefirst abutment surface is rotatable by rotating the dose setting elementout of contact with the engagement element, whereby the plunger rod isdisplaceable by the drive spring by a priming stroke in the distaldirection, wherein, at an end of the priming stroke, the engagementelement is in contact with a second abutment surface formed by therecess, whereby the movement of the plunger rod in the distal directionis blocked.
 16. The device of claim 15, wherein when the needleprotection sleeve is moved into the housing, the needle protectionsleeve displaces a switching sleeve from a position in which theswitching sleeve prevents the engagement element from being able to moveout of the recess of the plunger rod, in the proximal direction into arelease position in which the switching sleeve releases a movement ofthe engagement element out of the recess, whereby movement of theplunger rod in the distal direction is released for a discharge of a setdose.
 17. The device of claim 15, wherein the plunger rod is coupled ina rotationally fixed manner to the dose setting element, when theengagement element is in contact with the first abutment surface and/orthe second abutment surface of the recess, and is rotationally decoupledfrom the dose setting element during a discharge of a set dose or isrotationally decoupled when the dose selection abutment is in contactwith one of the dosing abutments, whereby the dose setting element isrotatable relative to the plunger rod.
 18. The device of claim 15,further comprising: a displacement unit, which is rotationally fixed andaxially displaceable in relation to the dosing sleeve; and a ring, whichis rotatable about the longitudinal axis and which is in an axiallyfixed, rotationally detachable engagement with the dosing sleeve,wherein the dose selection abutment of the plunger rod entrains thedisplacement unit toward an end of a discharge stroke, and wherein atransmission surface of the displacement unit slides on the ring,whereby the ring is turned about the longitudinal axis out of itsaxially fixed engagement with the dosing sleeve, so that a prestressedspring accelerates the ring against a coupling sleeve, whereby anacoustic and/or tactile signal is generated, which signals the end ofthe discharge of the selected dose.
 19. The device of claim 15, furthercomprising: a displacement unit, which is rotationally fixed and axiallydisplaceable in relation to the dosing sleeve; and a ring, which isrotatable about the longitudinal axis and which is in an axially fixed,rotationally detachable engagement with the dosing sleeve, which isloosenable by turning, wherein the dose selection abutment of theplunger rod entrains the displacement unit toward an end of a dischargestroke, and wherein a transmission surface of the displacement unitslides on the ring, whereby the ring is turned about the longitudinalaxis out of the axially fixed engagement which it is in with the dosingsleeve, so that a prestressed spring displaces the ring into a positionin which the ring engages in a rotationally fixed manner in a couplingsleeve which in turn is coupled in a rotationally fixed manner to thedose setting element, so that turning of the dose setting elementrelative to the housing is blocked.
 20. The device of claim 1, whereinthe dose selection abutment is formed on the dosing sleeve, wherein theat least one dosing abutment comprises at least a first dosing abutment,which is formed on the plunger rod, wherein the plunger rod isrotationally fixed in relation to the housing, wherein the dosing sleeveis connected in a rotationally fixed manner to the dose setting elementand is rotatable together with the dose setting element in relation tothe housing and/or the plunger rod, wherein the dosing sleeve isconnected in an axially fixed manner to the housing.